Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-29 @ 2:22 AM
Study NCT ID:
NCT05075668
Status:
COMPLETED
Last Update Posted:
2021-10-13
First Post:
2019-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of HFNC as an Alternative to CPAP Therapy in Surgical Patients With Suspected Moderate to Severe OSA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2019-11-13', 'studyFirstSubmitQcDate': '2021-09-29', 'lastUpdatePostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with documented desaturations (defined as >4% drop from baseline)', 'timeFrame': '10 hours (between 10pm on first postoperative night and 8am the following day)', 'description': 'Number of documented desaturations (defined as \\>4% below baseline) in OSA patients who receive CPAP face mask or high flow nasal insufflation on the first postoperative night'}], 'secondaryOutcomes': [{'measure': 'Number of participants who need for supplemental oxygen and/ or the need for other interventions to reverse the desaturations.', 'timeFrame': '10 hours (between 10pm on first postoperative night and 8am the following day)', 'description': 'Need for supplemental oxygen and/or the need for other interventions to reverse desaturations in OSA patients who receive CPAP face mask or high flow nasal insufflation on the first postoperative night'}, {'measure': "Patients' perceptions of the comfort of each device on scale of 0 to 100", 'timeFrame': '10 hours (between 10pm on first postoperative night and 8am the following day)', 'description': "The patients' perceptions of the comfort of CPAP face mask and/ or high flow nasal insufflation"}, {'measure': 'Number of participants with any adverse effects of the applied therapy in the immediate postoperative setting.', 'timeFrame': '10 hours (between 10pm on first postoperative night and 8am the following day)', 'description': 'OSA patients who receive CPAP face mask or high flow nasal insufflation on the first'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CPAP therapy', 'High flow nasal cannula'], 'conditions': ['OSA']}, 'referencesModule': {'references': [{'pmid': '23845744', 'type': 'BACKGROUND', 'citation': 'Gotera C, Diaz Lobato S, Pinto T, Winck JC. Clinical evidence on high flow oxygen therapy and active humidification in adults. Rev Port Pneumol. 2013 Sep-Oct;19(5):217-27. doi: 10.1016/j.rppneu.2013.03.005. Epub 2013 Jul 8.'}, {'pmid': '27698207', 'type': 'BACKGROUND', 'citation': 'Zhang J, Lin L, Pan K, Zhou J, Huang X. High-flow nasal cannula therapy for adult patients. J Int Med Res. 2016 Dec;44(6):1200-1211. doi: 10.1177/0300060516664621. Epub 2016 Oct 3.'}, {'pmid': '17363769', 'type': 'BACKGROUND', 'citation': 'McGinley BM, Patil SP, Kirkness JP, Smith PL, Schwartz AR, Schneider H. A nasal cannula can be used to treat obstructive sleep apnea. Am J Respir Crit Care Med. 2007 Jul 15;176(2):194-200. doi: 10.1164/rccm.200609-1336OC. Epub 2007 Mar 15.'}, {'pmid': '19952061', 'type': 'BACKGROUND', 'citation': 'Nilius G, Wessendorf T, Maurer J, Stoohs R, Patil SP, Schubert N, Schneider H. Predictors for treating obstructive sleep apnea with an open nasal cannula system (transnasal insufflation). Chest. 2010 Mar;137(3):521-8. doi: 10.1378/chest.09-0357. Epub 2009 Dec 1.'}, {'pmid': '25015548', 'type': 'BACKGROUND', 'citation': 'Sowho MO, Woods MJ, Biselli P, McGinley BM, Buenaver LF, Kirkness JP. Nasal insufflation treatment adherence in obstructive sleep apnea. Sleep Breath. 2015 Mar;19(1):351-7. doi: 10.1007/s11325-014-1027-4.'}, {'pmid': '25957615', 'type': 'BACKGROUND', 'citation': 'Nilius G, Franke KJ, Domanski U, Schroeder M, Ruhle KH. Effect of APAP and heated humidification with a heated breathing tube on adherence, quality of life, and nasopharyngeal complaints. Sleep Breath. 2016 Mar;20(1):43-9. doi: 10.1007/s11325-015-1182-2. Epub 2015 May 10.'}]}, 'descriptionModule': {'briefSummary': 'High flow, humidified, temperature-regulated nasal insufflation is not a new concept. It is used widely in the treatment of hypoxaemic respiratory failure in critically ill patients, as an alternative to non-invasive positive ventilation via face or nasal mask. Recently, its use has been extended to the perioperative setting for pre-oxygenation and prolonging apnoeic time to desaturation. Both CPAP and high flow nasal cannula insufflation devices are licensed for use clinically in Singapore. We conduct this pilot study because its perioperative use in our adult OSA population is currently not well-defined.', 'detailedDescription': "Continuous positive airway pressure (CPAP) therapy is the only treatment for obstructive sleep apnoea (OSA) shown to reduce its long-term adverse effects on the cardiovascular system. However, due to difficult patient-mask interface and discomfort, compliance rate amongst patients with OSA is low, and reported to be only between 20-50%. High flow, humidified, temperature-regulated nasal cannula insufflation (of air or oxygen) is a well-documented and safe treatment in intensive care, paediatrics and respiratory medicine for patients with hypoxaemic respiratory failure. Its use in adult patients with obstructive sleep apnoea, especially in the perioperative setting is not well studied. Our hospital has a ''fast-track'' protocol for OSA patients who require surgery. They are started on CPAP therapy 2 to 5 days prior to surgery and in the immediate post operative period (ie. perioperatively). If these patients are non-compliant to the CPAP mask device, high flow nasal insufflation is a possible alternative treatment. We aim to randomise these patients into 4 groups, receiving conventional CPAP face mask or high flow nasal cannula at 3 flow rates, and study them with respect to incidence and number of documented desaturations. In addition, patient satisfaction, compliance to device and any adverse events will be monitored."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 21-85 years old presenting for elective surgery.\n* Suspected/possible OSA patients who are enrolled in the "fast-track OSA protocol" in the pre-assessment clinic\n* Patients started on CPAP therapy at least one day pre-operatively\n* Patients who are admitted to the High Dependency unit for postoperative monitoring.\n\nExclusion Criteria:\n\n* Patients with nasal obstruction.\n* Patients undergoing nasal or facial surgery, or surgery to treat OSA (eg. uvulopalatopharyngoplasty).\n* Patients who already require a higher oxygen concentration (FiO2 \\> 0.21) preoperatively.'}, 'identificationModule': {'nctId': 'NCT05075668', 'briefTitle': 'Efficacy of HFNC as an Alternative to CPAP Therapy in Surgical Patients With Suspected Moderate to Severe OSA', 'organization': {'class': 'OTHER', 'fullName': 'Changi General Hospital'}, 'officialTitle': 'Continuous Positive Airway Pressure Therapy Via Conventional CPAP Face Mask Versus High Flow Nasal Cannula in OSA Patients on the First Postoperative Night- a Pilot Randomised Study', 'orgStudyIdInfo': {'id': '2018/2142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'OSA support via CPAP face mask', 'description': 'Auto-titrated according to the settings made by sleep physicians, FiO2 0.21', 'interventionNames': ['Device: CPAP face mask']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OSA support via HFNC at 20 L/min', 'description': 'High flow nasal insufflation of air (FiO2 0.21) at 20 L/min', 'interventionNames': ['Device: High flow nasal cannula (HFNC)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OSA support via HFNC at 30 L/min', 'description': 'High flow nasal insufflation of air (FiO2 0.21) at 30 L/min', 'interventionNames': ['Device: High flow nasal cannula (HFNC)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OSA support via HFNC at 40 L/min', 'description': 'High flow nasal insufflation of air (FiO2 0.21) at 40 L/min', 'interventionNames': ['Device: High flow nasal cannula (HFNC)']}], 'interventions': [{'name': 'CPAP face mask', 'type': 'DEVICE', 'description': 'Two types of CPAP therapy for OSA support are compared; CPAP face mask vs HFNC at different flow rates', 'armGroupLabels': ['OSA support via CPAP face mask']}, {'name': 'High flow nasal cannula (HFNC)', 'type': 'DEVICE', 'otherNames': ['Optiflow™ High Flow therapy; Fisher and Paykel'], 'description': 'Two types of CPAP therapy for OSA support are compared; CPAP face mask vs HFNC at different flow rates', 'armGroupLabels': ['OSA support via HFNC at 20 L/min', 'OSA support via HFNC at 30 L/min', 'OSA support via HFNC at 40 L/min']}]}, 'contactsLocationsModule': {'locations': [{'zip': '529889', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Changi General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Fung Chen Tsai, MMED (Anaes)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changi General Hospital, SingHealth'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant, Department of Anaesthesia & Surgical Intensive Care', 'investigatorFullName': 'Tsai Fung Chen', 'investigatorAffiliation': 'Changi General Hospital'}}}}