Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-05 @ 6:16 AM
Study NCT ID:
NCT02236559
Status:
COMPLETED
Last Update Posted:
2019-05-23
First Post:
2014-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
High Flow Therapy for the Treatment of Respiratory Failure in the ED
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pratik.b.doshi@uth.tmc.edu', 'title': 'Dr. Pratik Doshi, MD', 'organization': 'McGovern Medical School at The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Noninvasive Positive Pressure Ventilation', 'description': 'Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.', 'otherNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'High Velocity Nasal Insufflation', 'description': 'Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.', 'otherNumAtRisk': 104, 'otherNumAffected': 0, 'seriousNumAtRisk': 104, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Death Outside Study Window', 'notes': 'Cardiac arrest leading to death prior to discharge but outside the study window. Determined by the principal investigator to not be study related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Failure Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noninvasive Positive Pressure Ventilation', 'description': 'Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}, {'id': 'OG001', 'title': 'High Velocity Nasal Insufflation', 'description': 'Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}], 'classes': [{'categories': [{'title': 'Intubated at 72 Hours', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Not Intubated at 72 hours', 'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 72 hrs', 'description': 'Determine the efficacy of HFT compared to NIPPV in treating respiratory failure. The primary endpoint will be treatment failure within 72 hrs as determined by intubation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ventilatory Indices 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noninvasive Positive Pressure Ventilation', 'description': 'Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}, {'id': 'OG001', 'title': 'High Velocity Nasal Insufflation', 'description': 'Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}], 'classes': [{'title': 'Heart Rate at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '101', 'spread': '21.3', 'groupId': 'OG000'}, {'value': '100.4', 'spread': '21.2', 'groupId': 'OG001'}]}]}, {'title': 'Heart Rate at 30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.4', 'spread': '22', 'groupId': 'OG000'}, {'value': '95.6', 'spread': '20.4', 'groupId': 'OG001'}]}]}, {'title': 'Heart Rate at 60 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.7', 'spread': '20.4', 'groupId': 'OG000'}, {'value': '94', 'spread': '18.4', 'groupId': 'OG001'}]}]}, {'title': 'Heart Rate at 90 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.2', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '91.8', 'spread': '17.8', 'groupId': 'OG001'}]}]}, {'title': 'Heart Rate at 240 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.6', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '9.21', 'spread': '17.4', 'groupId': 'OG001'}]}]}, {'title': 'Heart Rate at Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '108.9', 'spread': '33.5', 'groupId': 'OG000'}, {'value': '106.4', 'spread': '29.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).', 'description': 'Evaluate the capability of high velocity nasal insufflation (HVNI), compared to non-invasive positive pressure ventialtion (NIPPV), to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia.', 'unitOfMeasure': 'beats per min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'If treatment failed prior to followup recording, subsequent data was not collected per the protocol.'}, {'type': 'SECONDARY', 'title': 'Ventilatory Indices 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noninvasive Positive Pressure Ventilation', 'description': 'Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}, {'id': 'OG001', 'title': 'High Velocity Nasal Insufflation', 'description': 'Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}], 'classes': [{'title': 'Respiratory Rate at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.3', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '31.3', 'spread': '8.2', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Rate at 30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.6', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '26.0', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Rate at 60 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.4', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '23.9', 'spread': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Rate at 90 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.7', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '22.9', 'spread': '5.8', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Rate at 240 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.1', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '22.2', 'spread': '4.7', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Rate at Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.4', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '26.4', 'spread': '11.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline, 30 minutes, 60 minutes, 90 minutes, 4 hours, and treatment failure if applicable', 'description': 'Evaluate the capability of high velocity nasal insufflation (HVNI), compared to non-invasive positive pressure ventilation (NIPPV), to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Respiratory rate recorded at one and four hours, and at treatment failure if applicable.', 'unitOfMeasure': 'breaths per min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'If treatment failed prior to followup recording, subsequent data was not collected per the protocol.'}, {'type': 'SECONDARY', 'title': 'Ventilatory Indices 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noninvasive Positive Pressure Ventilation', 'description': 'Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}, {'id': 'OG001', 'title': 'High Velocity Nasal Insufflation', 'description': 'Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}], 'classes': [{'title': 'SpO2 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.5', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '93.2', 'spread': '7', 'groupId': 'OG001'}]}]}, {'title': 'SpO2 at 30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.8', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '97.5', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'SpO2 at 60 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.8', 'spread': '3', 'groupId': 'OG000'}, {'value': '97.6', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'SpO2 at 90 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.7', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '97.8', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'SpO2 at 240 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.8', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '97.2', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'SpO2 at Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.4', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '93.3', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).', 'description': 'Evaluate the capability of high velocity nasal insufflation (HVNI), compared to non-invasive positive pressure ventilation (NIPPV), to affect indices of ventilation. The secondary endpoint is the degree of improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. SpO2 (a measurement of blood oxygen) recorded at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).', 'unitOfMeasure': '% SpO2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'If treatment failed prior to followup recording, subsequent data was not collected per the protocol.'}, {'type': 'SECONDARY', 'title': 'Ventilatory Indices 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noninvasive Positive Pressure Ventilation', 'description': 'Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}, {'id': 'OG001', 'title': 'High Velocity Nasal Insufflation', 'description': 'Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}], 'classes': [{'title': 'VAS at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'spread': '.5', 'groupId': 'OG000'}, {'value': '4', 'spread': '.5', 'groupId': 'OG001'}]}]}, {'title': 'VAS at 30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'VAS at 60 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'spread': '.5', 'groupId': 'OG000'}, {'value': '2', 'spread': '.5', 'groupId': 'OG001'}]}]}, {'title': 'VAS at 90 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'VAS at 240 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'spread': '.5', 'groupId': 'OG000'}, {'value': '2', 'spread': '.4', 'groupId': 'OG001'}]}]}, {'title': 'VAS at Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '3', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).', 'description': "Evaluate the capability of HFT, compared to NIPPV, to affect indices of ventilation. Patient discomfort as rated on a VAS recorded at one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).. NOTE: Due to need for patients to be alert and provide this rating, the number analyzed is less than the total patients in the trial.\n\nVAS: Visual Analogue Scale. A Likert scale of facial expressions ranging from a smiley face to a frowning face used to assess the subjects' subjective level of dyspnea. Minimum 0 (no discomfort) to Maximum 5 (maximum discomfort).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'If treatment failed prior to followup recording, subsequent data was not collected per the protocol. Some participants were unable to give scores due to health status.'}, {'type': 'SECONDARY', 'title': 'Ventilatory Indices 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noninvasive Positive Pressure Ventilation', 'description': 'Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}, {'id': 'OG001', 'title': 'High Velocity Nasal Insufflation', 'description': 'Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}], 'classes': [{'title': 'Borg Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.5', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'Borg Score at 30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Borg Score at 60 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Borg Score at 90 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Borg Score at 240 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Borg Score at Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '3', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable)', 'description': 'Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Modified Borg score recorded at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable). NOTE: Due to the need for patients to be alert and able to provide this score, the number analyzed is less than the total patients in the trial.\n\nA modified Borg scale was used to ask the patient to describe their effort on a scale of 0 to 10, where 10 is extreme discomfort.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'If treatment failed prior to followup recording, subsequent data was not collected per the protocol. Some participants were unable to give scores due to health status.'}, {'type': 'SECONDARY', 'title': 'Ventilatory Indices 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noninvasive Positive Pressure Ventilation', 'description': 'Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}, {'id': 'OG001', 'title': 'High Velocity Nasal Insufflation', 'description': 'Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}], 'classes': [{'title': 'pH at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.33', 'spread': '.08', 'groupId': 'OG000'}, {'value': '7.35', 'spread': '.1', 'groupId': 'OG001'}]}]}, {'title': 'pH at 60 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.34', 'spread': '.07', 'groupId': 'OG000'}, {'value': '7.36', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'pH at 240 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.36', 'spread': '.06', 'groupId': 'OG000'}, {'value': '7.38', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'pH at Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.19', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '7.25', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At one and four hours', 'description': 'Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (pH), a measurement of CO2 levels, recorded at one and four hours, and at treatment failure if applicable.\n\nNOTE: Due to test error, the number analyzed is less than the total patients in the trial.', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'If treatment failed prior to followup recording, subsequent data was not collected per the protocol.'}, {'type': 'SECONDARY', 'title': 'Ventilatory Indices 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noninvasive Positive Pressure Ventilation', 'description': 'Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}, {'id': 'OG001', 'title': 'High Velocity Nasal Insufflation', 'description': 'Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}], 'classes': [{'title': 'PCO2 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.7', 'spread': '25', 'groupId': 'OG000'}, {'value': '53.4', 'spread': '20.6', 'groupId': 'OG001'}]}]}, {'title': 'PCO2 at 60 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.2', 'spread': '21.5', 'groupId': 'OG000'}, {'value': '52.0', 'spread': '19.6', 'groupId': 'OG001'}]}]}, {'title': 'PCO2 at 240 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.5', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '46.3', 'spread': '12.7', 'groupId': 'OG001'}]}]}, {'title': 'PCO2 at Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.2', 'spread': '33.3', 'groupId': 'OG000'}, {'value': '69.2', 'spread': '32.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At one and four hours', 'description': 'Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (PCO2), a measure of CO2, recorded at one and four hours, and at treatment failure if applicable.\n\nNOTE: Due to test error, the number analyzed is less than the total patients in the trial.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'If treatment failed prior to followup recording, subsequent data was not collected per the protocol.'}, {'type': 'SECONDARY', 'title': 'Ventilatory Indices 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noninvasive Positive Pressure Ventilation', 'description': 'Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}, {'id': 'OG001', 'title': 'High Velocity Nasal Insufflation', 'description': 'Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}], 'classes': [{'title': 'HCO3 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.8', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '28.6', 'spread': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'HCO3 at 60 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.4', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '28.4', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'HCO3 at 240 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.3', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '26.9', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': 'HCO3 at Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.5', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '30.1', 'spread': '13.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At one and four hours', 'description': 'Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (HCO3), a meausre of blood oxygen/CO2 levels, recorded at one and four hours, and at treatment failure if applicable.\n\nNOTE: Due to test error, the number analyzed is less than the total patients in the trial.', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'If treatment failed prior to followup recording, subsequent data was not collected per the protocol.'}, {'type': 'SECONDARY', 'title': 'Ventilatory Indices 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noninvasive Positive Pressure Ventilation', 'description': 'Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}, {'id': 'OG001', 'title': 'High Velocity Nasal Insufflation', 'description': 'Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}], 'classes': [{'title': 'Base excess at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.87', 'spread': '7.76', 'groupId': 'OG000'}, {'value': '2.35', 'spread': '8.12', 'groupId': 'OG001'}]}]}, {'title': 'Base excess at 60 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.71', 'spread': '7.92', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '7.95', 'groupId': 'OG001'}]}]}, {'title': 'Base excess at 240 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.14', 'spread': '7.79', 'groupId': 'OG000'}, {'value': '1.47', 'spread': '5.48', 'groupId': 'OG001'}]}]}, {'title': 'Base excess at Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.12', 'spread': '13.75', 'groupId': 'OG000'}, {'value': '2.29', 'spread': '12.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At one and four hours', 'description': 'Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (base excess), a measure of blood oxygen/CO2 levels, recorded at one and four hours, and at treatment failure if applicable.\n\nNOTE: Due to test error, the number analyzed is less than the total patients in the trial.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'If treatment failed prior to followup recording, subsequent data was not collected per the protocol.'}, {'type': 'SECONDARY', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Noninvasive Positive Pressure Ventilation', 'description': 'Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}, {'id': 'OG001', 'title': 'High Velocity Nasal Insufflation', 'description': 'Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '5.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Duration of hospital visit', 'description': 'Evaluate the capability of HVNI, compared to NIPPV, to affect average length of stay.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Noninvasive Positive Pressure Ventilation', 'description': 'Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}, {'id': 'FG001', 'title': 'High Velocity Nasal Insufflation', 'description': 'High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort.The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '116'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Met Exclusion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Did not Meet Inclusion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Subject Did Not Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '24 patients randomized but not enrolled were excluded for meeting exclusion criteria (10), consent not obtained or withdrawn (6), bedside clinician not comfortable with enrollment after randomization (2), \\& patient identified to not need NiPPV after initial evaluation, thus failing to meet inclusion criteria (6). One patient met multiple criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Noninvasive Positive Pressure Ventilation (NiPPV)', 'description': 'Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of Noninvasive positive-pressure ventilation (NiPPV). NiPPV(Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}, {'id': 'BG001', 'title': 'High Velocity Nasal Insufflation (HVNI)', 'description': 'Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of High Velocity Nasal Insufflation (HVNI). HVNI (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.3', 'spread': '14.8', 'groupId': 'BG000'}, {'value': '63.4', 'spread': '13.6', 'groupId': 'BG001'}, {'value': '63.3', 'spread': '14.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'African', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': 'Latino', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Presenting Condition', 'classes': [{'categories': [{'title': 'Asthma', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Congestive Heart Failure', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Chronic heart failure', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Chronic Obstructive Pulmonary Disorder (COPD)', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'General dyspnea', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Discharge Diagnosis', 'classes': [{'categories': [{'title': 'Asthma', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Acute decompensated heart failure', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Acute COPD exacerbation', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Acute hypercapnic respiratory failure', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Acute hypoxic respiratory failure', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Acute hypercapnic and hypoxic respiratory failure', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Pneumonia/sepsis', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-25', 'studyFirstSubmitDate': '2014-09-08', 'resultsFirstSubmitDate': '2019-03-27', 'studyFirstSubmitQcDate': '2014-09-09', 'lastUpdatePostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-25', 'studyFirstPostDateStruct': {'date': '2014-09-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Failure Rate', 'timeFrame': 'Within 72 hrs', 'description': 'Determine the efficacy of HFT compared to NIPPV in treating respiratory failure. The primary endpoint will be treatment failure within 72 hrs as determined by intubation.'}], 'secondaryOutcomes': [{'measure': 'Ventilatory Indices 1', 'timeFrame': 'At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).', 'description': 'Evaluate the capability of high velocity nasal insufflation (HVNI), compared to non-invasive positive pressure ventialtion (NIPPV), to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia.'}, {'measure': 'Ventilatory Indices 2', 'timeFrame': 'At baseline, 30 minutes, 60 minutes, 90 minutes, 4 hours, and treatment failure if applicable', 'description': 'Evaluate the capability of high velocity nasal insufflation (HVNI), compared to non-invasive positive pressure ventilation (NIPPV), to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Respiratory rate recorded at one and four hours, and at treatment failure if applicable.'}, {'measure': 'Ventilatory Indices 3', 'timeFrame': 'At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).', 'description': 'Evaluate the capability of high velocity nasal insufflation (HVNI), compared to non-invasive positive pressure ventilation (NIPPV), to affect indices of ventilation. The secondary endpoint is the degree of improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. SpO2 (a measurement of blood oxygen) recorded at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).'}, {'measure': 'Ventilatory Indices 4', 'timeFrame': 'At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).', 'description': "Evaluate the capability of HFT, compared to NIPPV, to affect indices of ventilation. Patient discomfort as rated on a VAS recorded at one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).. NOTE: Due to need for patients to be alert and provide this rating, the number analyzed is less than the total patients in the trial.\n\nVAS: Visual Analogue Scale. A Likert scale of facial expressions ranging from a smiley face to a frowning face used to assess the subjects' subjective level of dyspnea. Minimum 0 (no discomfort) to Maximum 5 (maximum discomfort)."}, {'measure': 'Ventilatory Indices 5', 'timeFrame': 'at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable)', 'description': 'Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Modified Borg score recorded at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable). NOTE: Due to the need for patients to be alert and able to provide this score, the number analyzed is less than the total patients in the trial.\n\nA modified Borg scale was used to ask the patient to describe their effort on a scale of 0 to 10, where 10 is extreme discomfort.'}, {'measure': 'Ventilatory Indices 6', 'timeFrame': 'At one and four hours', 'description': 'Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (pH), a measurement of CO2 levels, recorded at one and four hours, and at treatment failure if applicable.\n\nNOTE: Due to test error, the number analyzed is less than the total patients in the trial.'}, {'measure': 'Ventilatory Indices 7', 'timeFrame': 'At one and four hours', 'description': 'Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (PCO2), a measure of CO2, recorded at one and four hours, and at treatment failure if applicable.\n\nNOTE: Due to test error, the number analyzed is less than the total patients in the trial.'}, {'measure': 'Ventilatory Indices 8', 'timeFrame': 'At one and four hours', 'description': 'Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (HCO3), a meausre of blood oxygen/CO2 levels, recorded at one and four hours, and at treatment failure if applicable.\n\nNOTE: Due to test error, the number analyzed is less than the total patients in the trial.'}, {'measure': 'Ventilatory Indices 9', 'timeFrame': 'At one and four hours', 'description': 'Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (base excess), a measure of blood oxygen/CO2 levels, recorded at one and four hours, and at treatment failure if applicable.\n\nNOTE: Due to test error, the number analyzed is less than the total patients in the trial.'}, {'measure': 'Length of Stay', 'timeFrame': 'Duration of hospital visit', 'description': 'Evaluate the capability of HVNI, compared to NIPPV, to affect average length of stay.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['high flow therapy', 'high flow nasal cannula', 'acute respiratory failure', 'noninvasive ventilation'], 'conditions': ['Acute Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '29310868', 'type': 'DERIVED', 'citation': 'Doshi P, Whittle JS, Bublewicz M, Kearney J, Ashe T, Graham R, Salazar S, Ellis TW Jr, Maynard D, Dennis R, Tillotson A, Hill M, Granado M, Gordon N, Dunlap C, Spivey S, Miller TL. High-Velocity Nasal Insufflation in the Treatment of Respiratory Failure: A Randomized Clinical Trial. Ann Emerg Med. 2018 Jul;72(1):73-83.e5. doi: 10.1016/j.annemergmed.2017.12.006. Epub 2018 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'The overall objective of this study is to determine if Vapotherm high flow nasal cannula therapy (HFT), when used to treat respiratory failure in the ED, is at least equivalent to the current standard of care for non-invasive ventilatory support, non-invasive positive pressure mask ventilation (NIPPV). Moreover, this study will investigate the potential that HFT has possible advantages over NIPPV, such as decreased time to patient stability from respiratory failure, and the ease of use as a first line intervention for respiratory failure in the ED environment.\n\nThe hypothesis is that HFT via the Vapotherm Precision Flow will demonstrate clinical non-inferiority when compared to NIPPV with regard to treatment failure by way of an impact on ventilation indices and a lower intolerance rate, and have a positive association with hospital disposition and length of stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (\\> 18 yrs of age)\n* Presentation with acute respiratory failure according to the following criteria:\n* If any of these are present: Respiratory Rate \\>22 or labored; Suspected Acute Respiratory Acidosis, as defined as pH \\<7.32 on initial blood gas(either arterial or venous); Hypoxemia, as defined as Pulse Ox \\<92%;\n* Clinical decision to escalate therapy to non-invasive ventilatory support, or to maintain non-invasive ventilatory support if delivered to the ED on such.\n\nExclusion Criteria:\n\n* Suspected drug overdose\n* Cardiovascular instability as demonstrated by hypotension relative to initial clinical presentation that requires immediate intervention\n* End stage cancer\n* Life expectancy \\< 6 months\n* Respiratory arrest or significant respiratory depression on presentation\n* Glasgow Coma Scale score \\< 9\n* Cardiac arrest on initial presentation\n* Need for emergent intubation\n* Known or suspected cerebrovascular accident\n* Known or suspected ST segment elevation myocardial infarction\n* Patients with increased risk of pulmonary aspiration\n* Agitation or uncooperativeness'}, 'identificationModule': {'nctId': 'NCT02236559', 'briefTitle': 'High Flow Therapy for the Treatment of Respiratory Failure in the ED', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vapotherm, Inc.'}, 'officialTitle': 'Vapotherm High Flow Therapy for the Treatment of Respiratory Failure in the ED: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RP-EDPF2014001Dev'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Noninvasive positive pressure ventilation', 'description': 'Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV. Initial pressures will be at low end of suggested range but can be increased as rapidly as necessary to alleviate respiratory distress. Targets should be to lower respiratory rate to the low 20s and achieve tidal volumes of 6-8 ml/kg ideal body weight. If patients find pressures uncomfortably high, they can be lowered as necessary by 1 to 2 cmH2O decrements to enhance tolerance. EPAP (PEEP) can also be adjusted upward as needed to reduce triggering effort (by counterbalancing auto-PEEP) or to improve oxygenation.\n\nFIO2 will be 1.0 initially to assure adequate oxygenation, but should be adjusted promptly to maintain an FIO2 of no greater than 0.6 with an EPAP (PEEP) of not more than 10 cm H2O to maintain a PaO2 \\> 88%.', 'interventionNames': ['Device: Noninvasive positive pressure ventilation (NIPPV)']}, {'type': 'EXPERIMENTAL', 'label': 'High flow therapy', 'description': 'Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. Initial flow will be set to 35 L/min but can be decreased or increased as rapidly as necessary to alleviate respiratory distress and optimize patient comfort. Targets should be to lower respiratory rate to the low 20s and with a HFT flow rate between 20 to 35 L/min. Starting temperature will be between 35 to 37 C; if patients find the gas temperature to be uncomfortable, it can be lowered as necessary down to 33 C to enhance tolerance.\n\nFIO2 will be 1.0 initially to assure adequate oxygenation, but should be adjusted promptly to maintain an FIO2 of no greater than 0.6 to maintain a PaO2 \\> 88%.', 'interventionNames': ['Device: Vapotherm']}], 'interventions': [{'name': 'Noninvasive positive pressure ventilation (NIPPV)', 'type': 'DEVICE', 'otherNames': ['BIPAP'], 'description': 'Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV. Initial pressures will be at low end of suggested range but can be increased as rapidly as necessary to alleviate respiratory distress. Targets should be to lower respiratory rate to the low 20s and achieve tidal volumes of 6-8 ml/kg ideal body weight. If patients find pressures uncomfortably high, they can be lowered as necessary by 1 to 2 cmH2O decrements to enhance tolerance. EPAP (PEEP) can also be adjusted upward as needed to reduce triggering effort (by counterbalancing auto-PEEP) or to improve oxygenation.\n\nFIO2 will be 1.0 initially to assure adequate oxygenation, but should be adjusted promptly to maintain an FIO2 of no greater than 0.6 with an EPAP (PEEP) of not more than 10 cm H2O to maintain a PaO2 \\> 88%.', 'armGroupLabels': ['Noninvasive positive pressure ventilation']}, {'name': 'Vapotherm', 'type': 'DEVICE', 'otherNames': ['High flow nasal cannula'], 'description': 'Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. Initial flow will be set to 35 L/min but can be decreased or increased as rapidly as necessary to alleviate respiratory distress and optimize patient comfort. Targets should be to lower respiratory rate to the low 20s and with a HFT flow rate between 20 to 35 L/min. Starting temperature will be between 35 to 37 C; if patients find the gas temperature to be uncomfortable, it can be lowered as necessary down to 33 C to enhance tolerance. FIO2 will be 1.0 initially to assure adequate oxygenation, but should be adjusted promptly to maintain an FIO2 of no greater than 0.6 to maintain a PaO2 \\> 88%.', 'armGroupLabels': ['High flow therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30606', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Athens Regional Medical Center', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'zip': '29506', 'city': 'Florence', 'state': 'South Carolina', 'country': 'United States', 'facility': 'McLeod Regional Medical Center', 'geoPoint': {'lat': 34.19543, 'lon': -79.76256}}, {'zip': '37403', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Erlanger Health System', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77380', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann The Woodlands', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}], 'overallOfficials': [{'name': 'Pratik B Doshi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}, {'name': 'Thomas L Miller, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vapotherm, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vapotherm, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Texas', 'class': 'OTHER'}, {'name': 'Memorial Hermann Texas Medical Center', 'class': 'UNKNOWN'}, {'name': 'Piedmont Athens Regional Medical Center', 'class': 'UNKNOWN'}, {'name': 'University of Tennessee', 'class': 'OTHER'}, {'name': 'Erlanger Medical Center', 'class': 'UNKNOWN'}, {'name': 'Memorial Hermann The Woodlands', 'class': 'UNKNOWN'}, {'name': 'McLeod Regional Medical Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}