Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-03-09 @ 4:05 AM
Study NCT ID:
NCT05524220
Status:
COMPLETED
Last Update Posted:
2025-04-22
First Post:
2022-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Nasal Positive Airway Pressure Versus Standard Care on Oxygenation and Ventilation During Propofol-based Sedation for Colonoscopy in Patients With High Risk of Airway Obstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Erikka.L.Washington@uth.tmc.edu', 'phone': '713-500-6202', 'title': 'Erikka Washington, MD', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From baseline to discharge (up to 24 hours)', 'eventGroups': [{'id': 'EG000', 'title': 'Group B: SuperNO2VA™EtCO2', 'description': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 0, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Group A: Standard Care With a Facemask.', 'description': 'Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 0, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'needed supplemental oxygen after procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'concern for bleeding after polyp removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time Taken From Initiation of Induction to the First Airway Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: SuperNO2VA™EtCO2', 'description': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)'}, {'id': 'OG001', 'title': 'Group A: Standard Care With a Facemask.', 'description': 'Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '11'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '15.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Initiation of Induction to the First Airway Intervention (about 16 minutes)', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '16 participants in the Group B: SuperNO2VA™EtCO2 needed airway intervention. 29 participants in the Group A: Standard care with a facemask needed airway intervention. Only the participants who needed airway intervention were analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Amount of Propofol Administered During Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: SuperNO2VA™EtCO2', 'description': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)'}, {'id': 'OG001', 'title': 'Group A: Standard Care With a Facemask.', 'description': 'Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '100'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 5 minutes of the start of anesthesia', 'unitOfMeasure': 'milligrams', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Amount of Propofol Administered During the Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: SuperNO2VA™EtCO2', 'description': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)'}, {'id': 'OG001', 'title': 'Group A: Standard Care With a Facemask.', 'description': 'Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)'}], 'classes': [{'categories': [{'measurements': [{'value': '360', 'groupId': 'OG000', 'lowerLimit': '220', 'upperLimit': '450'}, {'value': '253', 'groupId': 'OG001', 'lowerLimit': '200', 'upperLimit': '455'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'during the procedure (about 45 minutes)', 'unitOfMeasure': 'milligrams', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change in Alertness of Subject as Assessed by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: SuperNO2VA™EtCO2', 'description': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)'}, {'id': 'OG001', 'title': 'Group A: Standard Care With a Facemask.', 'description': 'Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)'}], 'timeFrame': 'prior to endoscopic intubation,during the procedure', 'description': 'This is scored from 0(no response)-5(response to your name spoken in a normal tone), a higher number indicating more alertness', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for this outcome measure because the assessment was not done by the observers. As a result, 0 observers completed the assessment, and therefore, no participants were analyzed in either study arm.'}, {'type': 'SECONDARY', 'title': 'Time Taken From Induction to Endoscopic Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: SuperNO2VA™EtCO2', 'description': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)'}, {'id': 'OG001', 'title': 'Group A: Standard Care With a Facemask.', 'description': 'Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'within 10 minutes of start of sedation', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Procedural Interruptions as Assessed by the Number of Times the Endoscope is Removed From the Patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: SuperNO2VA™EtCO2', 'description': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)'}, {'id': 'OG001', 'title': 'Group A: Standard Care With a Facemask.', 'description': 'Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)', 'unitOfMeasure': 'number of times endoscope is removed', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Procedural Interruptions as Assessed by the Length of Time the Endoscope is Removed From the Patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: SuperNO2VA™EtCO2', 'description': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)'}, {'id': 'OG001', 'title': 'Group A: Standard Care With a Facemask.', 'description': 'Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)'}], 'timeFrame': 'From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants had a procedural interruption.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received Airway Maneuvers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: SuperNO2VA™EtCO2', 'description': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)'}, {'id': 'OG001', 'title': 'Group A: Standard Care With a Facemask.', 'description': 'Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Taken for Airway Maneuvers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: SuperNO2VA™EtCO2', 'description': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)'}, {'id': 'OG001', 'title': 'Group A: Standard Care With a Facemask.', 'description': 'Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)'}], 'classes': [{'categories': [{'measurements': [{'value': '172.5', 'groupId': 'OG000', 'lowerLimit': '39.5', 'upperLimit': '1247'}, {'value': '131', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '621'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)', 'unitOfMeasure': 'seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '16 participants who received airway maneuvers in the Group B: SuperNO2VA™EtCO2 arm were analyzed for the outcome measure. 29 participants who received airway maneuvers in the Group A: Standard care with a facemask arm were analyzed for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Reason for Airway Maneuvers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: SuperNO2VA™EtCO2', 'description': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)'}, {'id': 'OG001', 'title': 'Group A: Standard Care With a Facemask.', 'description': 'Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)'}], 'classes': [{'title': 'Apnea', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Desaturations <90% SpO2', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Apnea and Desaturations <90% SpO2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '16 participants in the Group B: SuperNO2VA™EtCO2 needed airway intervention. 29 participants in the Group A: Standard care with a facemask needed airway intervention. Only the participants who needed airway intervention were analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time Taken for the Entire Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: SuperNO2VA™EtCO2', 'description': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)'}, {'id': 'OG001', 'title': 'Group A: Standard Care With a Facemask.', 'description': 'Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '44'}, {'value': '33.5', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '40.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from start of procedure to end of procedure (about 45 minutes)', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Recovery Time as Assessed by the Time When Subject Was Ready for Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: SuperNO2VA™EtCO2', 'description': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)'}, {'id': 'OG001', 'title': 'Group A: Standard Care With a Facemask.', 'description': 'Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '57'}, {'value': '46.5', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '56.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'at time of discharge( about one hour from end of procedure)', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Recovery Time as Assessed by the Actual Time When Subject Was Discharged', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: SuperNO2VA™EtCO2', 'description': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)'}, {'id': 'OG001', 'title': 'Group A: Standard Care With a Facemask.', 'description': 'Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '96'}, {'value': '77', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '92.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'at time of discharge( about one and a half hour from end of procedure)', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction as Assessed by the Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: SuperNO2VA™EtCO2', 'description': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)'}, {'id': 'OG001', 'title': 'Group A: Standard Care With a Facemask.', 'description': 'Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '10'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'at time of discharge(about one hour from end of procedure)', 'description': 'This will be scored from 0-10, a higher score indicating more satisfaction', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected from 3 participants in the Group B: SuperNO2VA™EtCO2 arm because the participants did not complete the survey. Data were not collected from 1 participant in the Group A: Standard care with a facemask arm because the participant did not complete the survey.'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Tolerated the SuperNO2VA™EtCO2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: SuperNO2VA™EtCO2', 'description': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from start of procedure to end of procedure (about 45 minutes)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Anesthesiologist Satisfaction Score as Assessed by the Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: SuperNO2VA™EtCO2', 'description': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)'}, {'id': 'OG001', 'title': 'Group A: Standard Care With a Facemask.', 'description': 'Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '10'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'end of procedure (about 45 minutes from start)', 'description': 'This will be scored from 0-10, a higher score indicating more satisfaction', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Had Incidences of Cardiac Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: SuperNO2VA™EtCO2', 'description': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)'}, {'id': 'OG001', 'title': 'Group A: Standard Care With a Facemask.', 'description': 'Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during the procedure (about 45 minutes)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group B: SuperNO2VA™EtCO2', 'description': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)'}, {'id': 'FG001', 'title': 'Group A: Standard Care With a Facemask.', 'description': 'Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group B: SuperNO2VA™EtCO2', 'description': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)'}, {'id': 'BG001', 'title': 'Group A: Standard Care With a Facemask.', 'description': 'Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000', 'lowerLimit': '51', 'upperLimit': '64'}, {'value': '54.5', 'groupId': 'BG001', 'lowerLimit': '48.5', 'upperLimit': '62'}, {'value': '56', 'groupId': 'BG002', 'lowerLimit': '50', 'upperLimit': '63'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'Black or African-American', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'American Society of Anesthesiology (ASA) Classification', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}], 'categories': [{'title': 'ASA I: A normal healthy patient', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'ASA II: A patient with mild systemic disease', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'ASA III: A patient with severe systemic disease', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'ASA IV: A patient with severe systemic disease that is a constant threat to life', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'ASA V: A moribund patient who is not expected to survive without the operation', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'ASA VI: A declared brain-dead patient whose organs are being removed for donor purposes', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "ASA Physical Status Classification System - The purpose of the system is to assess and communicate a patient's pre-anesthesia medical co-morbidities.\n\nASA I :A normal healthy patient ASA II :A patient with mild systemic disease ASA III: A patient with severe systemic disease ASA IV: A patient with severe systemic disease that is a constant threat to life ASA V: A moribund patient who is not expected to survive without the operation ASA VI: A declared brain-dead patient whose organs are being removed for donor purposes", 'unitOfMeasure': 'Participants', 'populationDescription': 'Data were not collected from 1 participant in the Group B: SuperNO2VA™EtCO2 arm.'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36.6', 'groupId': 'BG000', 'lowerLimit': '32.5', 'upperLimit': '40.9'}, {'value': '35.2', 'groupId': 'BG001', 'lowerLimit': '33.5', 'upperLimit': '39.7'}, {'value': '35.9', 'groupId': 'BG002', 'lowerLimit': '32.7', 'upperLimit': '40.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kilograms per square meter', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'categories': [{'title': '< 30', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '30 ≤ BMI < 40 (obesity)', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}, {'title': '≥ 40 (Class 3 obesity)', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-27', 'size': 602883, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-05T13:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2022-08-29', 'resultsFirstSubmitDate': '2024-08-07', 'studyFirstSubmitQcDate': '2022-08-29', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-12', 'studyFirstPostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time Taken From Initiation of Induction to the First Airway Intervention', 'timeFrame': 'From Initiation of Induction to the First Airway Intervention (about 16 minutes)'}], 'secondaryOutcomes': [{'measure': 'Amount of Propofol Administered During Induction', 'timeFrame': 'Within 5 minutes of the start of anesthesia'}, {'measure': 'Total Amount of Propofol Administered During the Procedure', 'timeFrame': 'during the procedure (about 45 minutes)'}, {'measure': "Change in Alertness of Subject as Assessed by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS)", 'timeFrame': 'prior to endoscopic intubation,during the procedure', 'description': 'This is scored from 0(no response)-5(response to your name spoken in a normal tone), a higher number indicating more alertness'}, {'measure': 'Time Taken From Induction to Endoscopic Insertion', 'timeFrame': 'within 10 minutes of start of sedation'}, {'measure': 'Incidence of Procedural Interruptions as Assessed by the Number of Times the Endoscope is Removed From the Patient', 'timeFrame': 'From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)'}, {'measure': 'Duration of Procedural Interruptions as Assessed by the Length of Time the Endoscope is Removed From the Patient', 'timeFrame': 'From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)'}, {'measure': 'Number of Participants Who Received Airway Maneuvers', 'timeFrame': 'From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)'}, {'measure': 'Time Taken for Airway Maneuvers', 'timeFrame': 'From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)'}, {'measure': 'Reason for Airway Maneuvers', 'timeFrame': 'From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)'}, {'measure': 'Time Taken for the Entire Procedure', 'timeFrame': 'from start of procedure to end of procedure (about 45 minutes)'}, {'measure': 'Recovery Time as Assessed by the Time When Subject Was Ready for Discharge', 'timeFrame': 'at time of discharge( about one hour from end of procedure)'}, {'measure': 'Recovery Time as Assessed by the Actual Time When Subject Was Discharged', 'timeFrame': 'at time of discharge( about one and a half hour from end of procedure)'}, {'measure': 'Patient Satisfaction as Assessed by the Visual Analog Scale (VAS)', 'timeFrame': 'at time of discharge(about one hour from end of procedure)', 'description': 'This will be scored from 0-10, a higher score indicating more satisfaction'}, {'measure': 'Number of Participants That Tolerated the SuperNO2VA™EtCO2', 'timeFrame': 'from start of procedure to end of procedure (about 45 minutes)'}, {'measure': 'Anesthesiologist Satisfaction Score as Assessed by the Visual Analog Scale (VAS)', 'timeFrame': 'end of procedure (about 45 minutes from start)', 'description': 'This will be scored from 0-10, a higher score indicating more satisfaction'}, {'measure': 'Number of Participants That Had Incidences of Cardiac Complications', 'timeFrame': 'during the procedure (about 45 minutes)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Obstructive Sleep Apnea', 'total IV anesthesia', 'obesity', 'colonoscopy', 'Nasal cpap'], 'conditions': ['Obstructive Sleep Apnea, Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to to compare oxygenation and ventilation on spontaneously ventilating obese patients or those with diagnosed or undiagnosed Obstructive sleep apnea (OSA) undergoing day colonoscopy under Propofol based sedation, between the SuperNO2VA Et™ nasal positive airway pressure (PAP) device and routine care with face mask for oxygen (O2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing colonoscopy\n* American Society of Anesthesiology (ASA) Physical Status I-III\n* BMI ≥30 kg/m2 or suspected Obstructive Sleep Apnea\n\nExclusion Criteria:\n\n* Inpatient status\n* Active Congestive Heart Failure Exacerbation\n* Untreated ischemic heart disease\n* Acute exacerbation of respiratory disorders, including Chronic obstructive pulmonary disease (COPD) and asthma\n* Emergent procedures\n* Pregnancy\n* Previous enrollment in this study\n* Inability to provide informed consent\n* Additional medical testing planned for the same day\n* History of allergic reaction to Propofol\n* Tracheostomy\n* Supra-glottic or sub-glottic tumor\n* Gastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon).\n* Prisoners\n* Unable to fit SuperNoVa'}, 'identificationModule': {'nctId': 'NCT05524220', 'briefTitle': 'Effect of Nasal Positive Airway Pressure Versus Standard Care on Oxygenation and Ventilation During Propofol-based Sedation for Colonoscopy in Patients With High Risk of Airway Obstruction', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Effect of Nasal Positive Airway Pressure Versus Standard Care on Oxygenation and Ventilation During Propofol-based Sedation for Colonoscopy in Patients With High Risk of Airway Obstruction: a Prospective Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'HSC-MS-22-0351'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A: Standard care with a facemask.', 'interventionNames': ['Device: Standard care with a facemask.']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: SuperNO2VA™EtCO2', 'interventionNames': ['Device: SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)']}], 'interventions': [{'name': 'Standard care with a facemask.', 'type': 'DEVICE', 'description': 'The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)', 'armGroupLabels': ['Group A: Standard care with a facemask.']}, {'name': 'SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)', 'type': 'DEVICE', 'description': 'The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)', 'armGroupLabels': ['Group B: SuperNO2VA™EtCO2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Erikka Washington, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vyaire Medical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Erikka L Washington', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}