Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-03-04 @ 8:30 AM
Study NCT ID:
NCT01925534
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2013-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Study of High-flow Humidified Nasal Oxygen During Breaks From Noninvasive Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nhill@tuftsmedicalcenter.org', 'phone': '(617) 636-6377', 'title': 'Dr. Nicholas Hill', 'organization': 'Tufts Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Optiflow', 'description': 'High-flow humidified nasal oxygen delivery system\n\nHigh-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 11, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Oxygen Therapy', 'description': 'Standard oxygen therapy\n\nStandard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 15, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasal Dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'endotracheal intubation (ETI)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Length of Stay on Noninvasive Ventilation (NIV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Optiflow', 'description': 'High-flow humidified nasal oxygen delivery system\n\nHigh-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.'}, {'id': 'OG001', 'title': 'Oxygen Therapy', 'description': 'Standard oxygen therapy\n\nStandard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.'}], 'classes': [{'categories': [{'measurements': [{'value': '1404', 'spread': '1386', 'groupId': 'OG000'}, {'value': '1386', 'spread': '951', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1-7', 'description': 'The investigator will measure the total time on NIV in day(s), hours and minutes. This is done by having nursing staff note times of NIV start to finish of each session of NIV. They were added to get cumulative time.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Breaks From NIV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Optiflow', 'description': 'High-flow humidified nasal oxygen delivery system\n\nHigh-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.'}, {'id': 'OG001', 'title': 'Oxygen Therapy', 'description': 'Standard oxygen therapy\n\nStandard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.'}], 'classes': [{'categories': [{'measurements': [{'value': '1345', 'spread': '902', 'groupId': 'OG000'}, {'value': '1221', 'spread': '770', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 4-10', 'description': 'This is done by having nursing staff note times of break start (off NIV) to start of next session of NIV in minutes. Subgroup analysis was performed to assess differences between hypercapnic and hypoxemic patients, not observed in terms of time spent on or off NIV.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assessment of Respiratory Rate During Break', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Optiflow', 'description': 'High-flow humidified nasal oxygen delivery system\n\nHigh-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.'}, {'id': 'OG001', 'title': 'Oxygen Therapy', 'description': 'Standard oxygen therapy\n\nStandard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.'}], 'classes': [{'title': 'Respiratory Rate: Break', 'categories': [{'measurements': [{'value': '23.8', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '21.8', 'spread': '5.2', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Rate: NIV', 'categories': [{'measurements': [{'value': '23.3', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '20.1', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 1-4', 'description': 'Evaluation of respiratory rate. This was counted for a minute at bedside at start and finish of break.', 'unitOfMeasure': 'breaths/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two groups randomly allocated to High Flow or Standard oxygen therapy'}, {'type': 'SECONDARY', 'title': "Patients' Comfort", 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Optiflow', 'description': 'High-flow humidified nasal oxygen delivery system\n\nHigh-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.'}, {'id': 'OG001', 'title': 'Oxygen', 'description': 'Standard oxygen therapy\n\nStandard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.'}], 'classes': [{'title': 'VAS Comfort Score Break', 'categories': [{'measurements': [{'value': '8.3', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'VAS Comfort Score NIV', 'categories': [{'measurements': [{'value': '5.9', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 2-4', 'description': 'Using a visual analogue scale (VAS). Patients rate how comfortable they felt on a 1 to 10 scale with 10 being most comfortable and 1 being the least comfortable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oxygen Saturation During Breaks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Optiflow', 'description': 'High-flow humidified nasal oxygen delivery system\n\nHigh-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.'}, {'id': 'OG001', 'title': 'Oxygen Therapy', 'description': 'Standard oxygen therapy\n\nStandard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.'}], 'classes': [{'title': 'SpO2, % mean: Break', 'categories': [{'measurements': [{'value': '94.1', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '94.7', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'SpO2, % final: Break', 'categories': [{'measurements': [{'value': '93.7', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '95.4', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'SpO2, % final: NIV', 'categories': [{'measurements': [{'value': '95.9', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '96.4', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 1-4', 'description': 'Using pulse oximetry (SpO2) at beginning and end of breaks', 'unitOfMeasure': 'arterial oxygen saturation (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Need for Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Optiflow', 'description': 'High-flow humidified nasal oxygen delivery system\n\nHigh-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.'}, {'id': 'OG001', 'title': 'Oxygen Therapy', 'description': 'Standard oxygen therapy\n\nStandard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 2-10', 'description': 'Count of participants who underwent endotracheal intubation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ease of Eating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Optiflow', 'description': 'High-flow humidified nasal oxygen delivery system\n\nHigh-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.'}, {'id': 'OG001', 'title': 'Oxygen Therapy', 'description': 'Standard oxygen therapy\n\nStandard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1-4', 'description': 'difficulty eating using patient rating on a visual analog scale of 0 for easy eating and 4 for difficult eating. Results tabulated as number of patients finding it easy to eat (Score of 0-1)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Optiflow', 'description': 'High-flow humidified nasal oxygen delivery system\n\nHigh-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.'}, {'id': 'FG001', 'title': 'Oxygen Therapy', 'description': 'Standard oxygen therapy\n\nStandard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Optiflow', 'description': 'High-flow humidified nasal oxygen delivery system\n\nHigh-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.'}, {'id': 'BG001', 'title': 'Oxygen Therapy', 'description': 'Standard oxygen therapy\n\nStandard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.9', 'spread': '13.8', 'groupId': 'BG000'}, {'value': '63.4', 'spread': '14.0', 'groupId': 'BG001'}, {'value': '66.17', 'spread': '13.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-06', 'studyFirstSubmitDate': '2013-07-31', 'resultsFirstSubmitDate': '2021-11-15', 'studyFirstSubmitQcDate': '2013-08-15', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-06', 'studyFirstPostDateStruct': {'date': '2013-08-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of Stay on Noninvasive Ventilation (NIV)', 'timeFrame': 'Day 1-7', 'description': 'The investigator will measure the total time on NIV in day(s), hours and minutes. This is done by having nursing staff note times of NIV start to finish of each session of NIV. They were added to get cumulative time.'}], 'secondaryOutcomes': [{'measure': 'Length of Breaks From NIV', 'timeFrame': 'Day 4-10', 'description': 'This is done by having nursing staff note times of break start (off NIV) to start of next session of NIV in minutes. Subgroup analysis was performed to assess differences between hypercapnic and hypoxemic patients, not observed in terms of time spent on or off NIV.'}, {'measure': 'Assessment of Respiratory Rate During Break', 'timeFrame': 'day 1-4', 'description': 'Evaluation of respiratory rate. This was counted for a minute at bedside at start and finish of break.'}, {'measure': "Patients' Comfort", 'timeFrame': 'Day 2-4', 'description': 'Using a visual analogue scale (VAS). Patients rate how comfortable they felt on a 1 to 10 scale with 10 being most comfortable and 1 being the least comfortable.'}, {'measure': 'Oxygen Saturation During Breaks', 'timeFrame': 'day 1-4', 'description': 'Using pulse oximetry (SpO2) at beginning and end of breaks'}, {'measure': 'Need for Intubation', 'timeFrame': 'Days 2-10', 'description': 'Count of participants who underwent endotracheal intubation'}, {'measure': 'Ease of Eating', 'timeFrame': 'Day 1-4', 'description': 'difficulty eating using patient rating on a visual analog scale of 0 for easy eating and 4 for difficult eating. Results tabulated as number of patients finding it easy to eat (Score of 0-1)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Optiflow', 'Humidified high-flow oxygen therapy', 'Noninvasive ventilation', 'Acute respiratory failure', 'Standard oxygen therapy'], 'conditions': ['Acute Respiratory Failure', 'Treatment With Noninvasive Positive Pressure Ventilation']}, 'referencesModule': {'references': [{'pmid': '19294364', 'type': 'BACKGROUND', 'citation': 'Ricard JD, Boyer A. Humidification during oxygen therapy and non-invasive ventilation: do we need some and how much? Intensive Care Med. 2009 Jun;35(6):963-5. doi: 10.1007/s00134-009-1457-9. Epub 2009 Mar 18. No abstract available.'}, {'pmid': '23013907', 'type': 'BACKGROUND', 'citation': 'El-Khatib MF. High-flow nasal cannula oxygen therapy during hypoxemic respiratory failure. Respir Care. 2012 Oct;57(10):1696-8. doi: 10.4187/respcare.02072. No abstract available.'}, {'pmid': '21946925', 'type': 'BACKGROUND', 'citation': 'Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.'}, {'pmid': '20406507', 'type': 'BACKGROUND', 'citation': 'Roca O, Riera J, Torres F, Masclans JR. High-flow oxygen therapy in acute respiratory failure. Respir Care. 2010 Apr;55(4):408-13.'}, {'pmid': '21496369', 'type': 'BACKGROUND', 'citation': 'Parke RL, Eccleston ML, McGuinness SP. The effects of flow on airway pressure during nasal high-flow oxygen therapy. Respir Care. 2011 Aug;56(8):1151-5. doi: 10.4187/respcare.01106. Epub 2011 Apr 15.'}, {'pmid': '21908497', 'type': 'BACKGROUND', 'citation': 'Corley A, Caruana LR, Barnett AG, Tronstad O, Fraser JF. Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients. Br J Anaesth. 2011 Dec;107(6):998-1004. doi: 10.1093/bja/aer265. Epub 2011 Sep 9.'}, {'pmid': '21255498', 'type': 'BACKGROUND', 'citation': 'Parke RL, McGuinness SP, Eccleston ML. A preliminary randomized controlled trial to assess effectiveness of nasal high-flow oxygen in intensive care patients. Respir Care. 2011 Mar;56(3):265-70. doi: 10.4187/respcare.00801. Epub 2011 Jan 21.'}, {'pmid': '23128844', 'type': 'BACKGROUND', 'citation': 'Braunlich J, Beyer D, Mai D, Hammerschmidt S, Seyfarth HJ, Wirtz H. Effects of nasal high flow on ventilation in volunteers, COPD and idiopathic pulmonary fibrosis patients. Respiration. 2013;85(4):319-25. doi: 10.1159/000342027. Epub 2012 Nov 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether Optiflow, a high-flow humidified oxygen delivery system, is superior to standard oxygen therapy during breaks off noninvasive ventilation in patients affected by acute respiratory failure and in respiratory distress. The investigators anticipate that the Optiflow will provide oxygen more effectively, be more comfortable and permit longer breaks off NIV, shortening the total duration of NIV.', 'detailedDescription': "Background: Noninvasive ventilation (NIV) provides respiratory support to many patients affected by acute respiratory failure. This treatment, compared to invasive mechanical ventilation, allows patients to take intermittent breaks during which oxygen therapy is provided through a nasal cannula or mask. During these breaks, the lack of ventilator support may predispose to respiratory distress, retention of CO2 and oxygen desaturation. Optiflow is a nasal humidified (37◦C, 44mg/L H2O) high-flow (up to 60 L/min) therapy which can provide greater support than standard oxygen therapy during the breaks from NIV.\n\nAim of the study is to evaluate Optiflow as an alternative to standard oxygen therapy during breaks from NIV in patients with acute respiratory failure. The investigators hypothesize tha Optiflow will reduce the total length of stay on NIV, and increase the comfort and length of the breaks. Also, the investigators anticipate that it will reduce respiratory rate, accessory muscle use and dyspnea score compared to standard oxygen therapy.\n\nExperimental design Prospective open-label, parallel, randomized (1:1) controlled study, with a target enrollment of 70.\n\nStudy procedures Enrolled patients receiving NIV will be randomized into two arms; a treatment group which will receive Optiflow during breaks and a control arm which will receive standard oxygen therapy during breaks. In both cases, FiO2 will be titrated to maintain oxygen saturation above 90%. The necessity of breaks will be determined together with the patients (talk, eat, medication, communicate with family, inability to tolerate the interface), and the need to resume NIV will be based on clinical data, such as dyspnea, respiratory rate, heart rate, blood pressure, oxygen saturation, transcutaneous carbon dioxide (CO2) and patients' desire.\n\nRecorded data: The investigators will record demographic baseline data; Glasgow Coma Scale, respiratory and heart rate, blood pressure, dyspnea score, accessory muscle use, and comfort score at randomization, at the end of each NIV session and NIV break; the length of each NIV session and break; the medications administered and all the arterial blood gases (ABG) on a daily basis. Moreover the investigators will record the NIV parameters and inspired oxygen fraction (FiO2) at each session and break.\n\nRisks: The investigators don't anticipate any significant risks related to the study procedures and equipment. Some patients may not tolerate the Optiflow and some patients may fail NIV and require intubation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of 18 or more years of age treated with Bipap or CPAP as per hospital protocol, with an underlying clinical diagnosis of acute respiratory failure.\n* Patients that, prior to administration of NIV, had persistent respiratory acidosis with a pH \\<7.35 and arterial CO2 \\> 45 mmHg despite controlled oxygen therapy and standard medical management i.e. bronchodilators, corticosteroids and antibiotics, or\n* Patients with hypoxemic respiratory failure with a PaO2/FiO2 ratio \\< 300 and respiratory rate ≥ 24.\n* Anticipated duration on NIV of at least 24 hrs\n\nExclusion criteria:\n\n* Usual contraindications to NIV\n* Respiratory arrest\n* Unable to fit mask\n* Medically unstable or multiple organ failure or unstable coronary disease\n* Agitated or uncooperative\n* Unable to protect airways\n* Swallowing difficulties\n* Excessive secretions not managed by clearance techniques\n* Recent upper airway or gastro-intestinal surgery\n* Facial deformity or previous head and neck surgery\n* Undrained pneumothorax\n* NIV failure within first 2 hours (either intolerance or requirement for intubation)\n* Managed for greater than 48 hours on NIV prior to randomization\n* Disorientation, confusion, unable to rate comfort or dyspnea\n* Expected to require NIV for fewer than 24 hrs from the time of enrollment\n* Patient previously in study\n* Patients on CPAP nighttime only due to OSA\n\nWithdrawal/Termination criteria:\n\n* Patients will be withdrawn from the study when NIV fails and/or the patient is intubated.'}, 'identificationModule': {'nctId': 'NCT01925534', 'acronym': 'OPTINIV', 'briefTitle': 'Pilot Study of High-flow Humidified Nasal Oxygen During Breaks From Noninvasive Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Tufts Medical Center'}, 'officialTitle': 'Pilot Study of Optiflow as a NIV Rest Therapy', 'orgStudyIdInfo': {'id': 'FPH-OF13-01'}, 'secondaryIdInfos': [{'id': 'IRB-10967', 'type': 'OTHER', 'domain': 'IRB Tufts Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Optiflow', 'description': 'High-flow humidified nasal oxygen delivery system', 'interventionNames': ['Device: High-flow humidified nasal oxygen delivery system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxygen therapy', 'description': 'Standard oxygen therapy', 'interventionNames': ['Device: Standard oxygen therapy']}], 'interventions': [{'name': 'High-flow humidified nasal oxygen delivery system', 'type': 'DEVICE', 'otherNames': ['Optiflow'], 'description': 'During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.', 'armGroupLabels': ['Optiflow']}, {'name': 'Standard oxygen therapy', 'type': 'DEVICE', 'description': 'During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.', 'armGroupLabels': ['Oxygen therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Intensive Care Unit and Intermediate Care Unit, Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01890', 'city': 'Winchester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Intensive Care Unit, Winchester Hospital', 'geoPoint': {'lat': 42.45232, 'lon': -71.137}}], 'overallOfficials': [{'name': 'Nicholas S Hill, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fisher and Paykel Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}