Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:50 PM
Study NCT ID:
NCT07307560
Status:
RECRUITING
Last Update Posted:
2026-02-27
First Post:
2025-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'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': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2025-12-14', 'studyFirstSubmitQcDate': '2025-12-14', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The incidence of other adverse events', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average about 2 hours', 'description': 'Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force'}], 'primaryOutcomes': [{'measure': 'The incidence of hypoxia', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average about 2 hours', 'description': '75% ≤ SpO2 \\< 90% for \\<60 s'}], 'secondaryOutcomes': [{'measure': 'The incidence of sub-clinical respiratory depression', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average about 2 hours', 'description': '90% ≤ SpO2 \\< 95%'}, {'measure': 'The incidence of severe hypoxia', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average about 2 hours', 'description': 'SpO2 \\< 75% or 75% ≤ SpO2 \\< 90% for ≥60 s'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sedation', 'Hypoxia', 'Obstructive Sleep Apnea (OSA)', 'Gastrointestinal Endoscopy'], 'conditions': ['Hypoxia', 'Esophageal Cancer', 'Gastric Cancer (Diagnosis)', 'Obstructive Sleep Apnea (OSA)']}, 'descriptionModule': {'briefSummary': 'Hypoxia represents the most frequent adverse event during propofol-sedated gastrointestinal endoscopy. The STOP-BANG questionnaire serves as a widely adopted, straightforward tool for screening obstructive sleep apnea (OSA) risk, with a score ≥5 identifying high-risk OSA patients who are particularly susceptible to hypoxia under sedation. Although preliminary research from our team suggests that High-Flow Nasal Cannula (HFNC) may lower the incidence of hypoxemia, evidence remains limited and inconsistent in studies specifically targeting high-risk OSA populations. Therefore, this multicenter randomized controlled trial aims to evaluate whether HFNC can effectively reduce the occurrence of hypoxia during sedated gastrointestinal endoscopy in patients identified as high-risk for OSA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years.\n* STOP-Bang score ≥5.\n* Scheduled for sedated gastrointestinal endoscopy (gastroscopy, colonoscopy, or combined gastroscopy + colonoscopy).\n* The estimated duration of the procedure does not exceed 45 minutes.\n* Patients have signed the informed consent form.\n\nExclusion Criteria:\n\n* Coagulation disorders or bleeding tendency (e.g., oral/nasal bleeding risk, mucosal injury, space-occupying obstructions).\n* Active upper respiratory tract infection (oral, nasal, or pharyngeal), or fever (core temperature \\>37.5°C).\n* Chronic obstructive pulmonary disease or other acute/chronic pulmonary diseases requiring long-term or intermittent oxygen therapy, or preoperative SpO₂ ≤ 92% on room air.\n* Severe organ dysfunction, including: Cardiac insufficiency (\\<4 METs), Severe renal insufficiency (requiring dialysis), Diagnosed severe hepatic insufficiency, Increased intracranial pressure, ASA physical status ≥ IV.\n* Confirmed pregnancy or current breastfeeding.\n* Known allergy to sedatives (e.g., propofol) or medical adhesives.\n* Multiple traumatic injuries.\n* Current participation in another clinical trial.\n* Other conditions deemed unsuitable by the investigator'}, 'identificationModule': {'nctId': 'NCT07307560', 'briefTitle': 'High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients: A Multicenter Randomized Trial', 'orgStudyIdInfo': {'id': 'ZJU2025C207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-flow nasal cannula Group', 'description': 'In this group, patients use the High-flow nasal cannula', 'interventionNames': ['Device: High-flow nasal cannula Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Regular Nasal Cannula Group', 'description': 'In this group, patients use the regular nasal cannula for oxygenation.', 'interventionNames': ['Device: Regular Nasal Cannula']}], 'interventions': [{'name': 'High-flow nasal cannula Group', 'type': 'DEVICE', 'description': 'Using High-flow nasal cannula oxygenation', 'armGroupLabels': ['High-flow nasal cannula Group']}, {'name': 'Regular Nasal Cannula', 'type': 'DEVICE', 'description': 'Using regular nasal cannula for oxygenation', 'armGroupLabels': ['Regular Nasal Cannula Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Diansan Su, Dr', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '+8618616514088'}], 'facility': 'The First Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '314000', 'city': 'Jiaxing', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huadong Ni, Dr', 'role': 'CONTACT', 'email': 'huadongni@zjxu.edu.cn', 'phone': '+86 15068386387'}], 'facility': 'The First Hospital Of Jiaxing', 'geoPoint': {'lat': 30.7522, 'lon': 120.75}}, {'zip': '324000', 'city': 'Quzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huiling Yu, Dr', 'role': 'CONTACT', 'email': '1608980221@qq.com', 'phone': '+86 13059727022'}], 'facility': "Quzhou People's Hospital", 'geoPoint': {'lat': 28.95944, 'lon': 118.86861}}], 'centralContacts': [{'name': 'Diansan Su, Chief Physician', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '+8618616514088'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician,Researcher', 'investigatorFullName': 'Diansan Su', 'investigatorAffiliation': 'Zhejiang University'}}}}