Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-28 @ 10:04 PM
Study NCT ID:
NCT06306651
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Flow Nasal Cannula and Conventional Oxygen Therapy in the Postoperative Management of Patients With Mild to Moderate Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-16', 'studyFirstSubmitDate': '2024-03-03', 'studyFirstSubmitQcDate': '2024-03-10', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen desaturation index', 'timeFrame': 'During intensive care unit stay (assessed up to day 5)', 'description': 'Oxygen desaturation index will be recorded through by pulse oximeter, while respiratory rate will be recorded by the ECG monitoring and visual count hourly.\n\nThe number of recorded drops in baseline SpO2 of \\>4%.'}], 'secondaryOutcomes': [{'measure': 'The length of Intensive care unit stay', 'timeFrame': 'At the time of intensive care unit discharge (up to day 5)', 'description': 'The length of Intensive care unit stay will be measured from the start of surgery until the discharge.'}, {'measure': 'The incidence of ventilatory support', 'timeFrame': 'At the time of intensive care unit discharge (up to day 5)', 'description': 'The incidence of ventilatory support is either non-invasive ventilation (NIV) and continuous positive airway pressure (CPAP) or intubation and mechanical ventilation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High Flow Nasal Cannula', 'Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effectiveness of conventional oxygen therapy oxygen and high-flow nasal cannula therapy on oxygen saturation (SpO2), measuring number of SpO2 drop \\>4% of base line oxygen saturation (o2 desaturation index), length of the ICU stay, and the need of use supplemental continuous positive airway pressure (CPAP) support in any of the study groups in the postoperative ICU setting.', 'detailedDescription': 'In the surgical setting, patients with obstructive sleep apnea (OSA) may have increased upper airway collapsibility affecting ventilation and increased sensitivity to sedation from anesthetics and opioids.\n\nSurgical patients with OSA have a high risk for postoperative complications, including cardiac events, hypoxemia, and transfer to the intensive care unit . Continuous positive airway pressure (CPAP) is the gold standard treatment for moderate to severe OSA , and effectively reduces the risk of cardiovascular events. Evidence has shown that CPAP effectively reduces length of ICU stay (LOS) in the postoperative setting. In these scenarios, conventional oxygen therapy and high-flow nasal cannula (HFNC) therapy have been used as an alternative for CPAP non-adherent patients.\n\nHFNC delivers warm, humidified air through a nasal cannula at high flow rates of up to 60 L/min. This high flow rate may increase end-expiratory pharyngeal pressure up to 3 cm H2O, decreasing the force required to alleviate airway collapse . Using a nasal cannula interface in contrast to the CPAP mask may provide a more comfortable experience for patients during sleep .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age group from 21 - 40 years old.\n* Both sexes.\n* Mild to moderate obstructive sleep apnea (OSA) patients with STOP-BANG score less than 5.\n* OSA patients undergoing non cardiac surgeries.\n* Patients who will undergo scheduled elective surgeries under general anesthesia.\n\nExclusion Criteria:\n\n* Patient refusal of procedure or participation in the study.\n* Patients with severe OSA, STOP-BANG score more than or equal 5.\n* Patients dependent on home ventilation CPAP or bilevel devices.\n* Pregnant females.\n* Post cardiac or thoracic surgery patients.\n* More than American Society of Anesthesiologists (ASA) II patients.\n* Head and face trauma patients.'}, 'identificationModule': {'nctId': 'NCT06306651', 'briefTitle': 'High Flow Nasal Cannula and Conventional Oxygen Therapy in the Postoperative Management of Patients With Mild to Moderate Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Comparative Study Between High Flow Nasal Cannula and Conventional Oxygen Therapy in the Postoperative Management of Patients With Mild to Moderate Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': 'FMASU MD283/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High flow nasal cannula therapy group', 'description': 'Patients who will be randomized to high flow nasal cannula therapy. High flow nasal oxygen cannula will be applied at a flow of 20 L/min at FiO2 of 0.4 at a temperature of 36oC.', 'interventionNames': ['Other: High flow nasal cannula therapy group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional oxygen therapy group', 'description': 'Patients who will be randomized to simple oxygen mask therapy. The simple face mask will be applied in a rate range between 6-10 L/min.', 'interventionNames': ['Other: Conventional oxygen therapy group']}], 'interventions': [{'name': 'High flow nasal cannula therapy group', 'type': 'OTHER', 'description': 'Patients who will be randomized to high flow nasal cannula therapy. High flow nasal oxygen cannula will be applied at a flow of 20 L/min at FiO2 of 0.4 at a temperature of 36oC', 'armGroupLabels': ['High flow nasal cannula therapy group']}, {'name': 'Conventional oxygen therapy group', 'type': 'OTHER', 'description': 'Patients who will be randomized to simple oxygen mask therapy. The simple face mask will be applied in a rate range between 6-10 L/min.', 'armGroupLabels': ['Conventional oxygen therapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Omar M Mohamed, Master', 'role': 'CONTACT', 'email': 'omarmedhat0100565@med.asu.edu.eg', 'phone': '00201063190923'}, {'name': 'Bahaa A Ali, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Adel M Alansary, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nora M Mahmoud, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mohamed M Abdallah, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Omar M Mohamed, Master', 'role': 'CONTACT', 'email': 'omarmedhat0100565@med.asu.edu.eg', 'phone': '00201063190923'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt.', 'investigatorFullName': 'Omar medhat', 'investigatorAffiliation': 'Ain Shams University'}}}}