Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT07252102
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of High Flow Nasal Cannula Oxygenation on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients : A Multicentre Randomised Controlled Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D003111', 'term': 'Colonic Polyps'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2025-11-19', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', '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': 'Incidence of hypoxia', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average about 2 hours', 'description': '75%≤ SpO2 \\< 90% and \\< 60S'}], 'secondaryOutcomes': [{'measure': 'Incidence of severe hypoxia', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average about 2 hours', 'description': 'SpO2\\<75% for any duration, or 75%≤SpO2 \\< 90%, ≥60s'}, {'measure': 'Incidence of subclinical respiratory depression', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average about 2 hours', 'description': '90%≤ SpO2\\<95%'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['critical patients', 'HFNC', 'High flow nasal cannulas oxyge', 'hypoxia'], 'conditions': ['Liver Cirrhosis', 'Polyps of Colon', 'Gastrointestinal Dysfunction']}, 'descriptionModule': {'briefSummary': 'High flow nasal cannula oxygenation (HFNC) offers high flow and concentration oxygen delivery, providing excellent non-respiratory oxygenation. As a relatively new oxygen delivery method, it has gained widespread use. We have demonstrated that high flow nasal cannula oxygenation reduce the incidence of hypoxia during sedated gastrointestinal endoscopy in patients with American Anesthesiologist Rating (ASA rating) grades 1 to 2 and obesity. We hypothesized that HFNC could mitigate the risk of hypoxia in critical patients during sedated gastrointestinal endoscopy. To confirm this, we selected critical patients with ASA grades 3 to 4 who were scheduled for gastrointestinal endoscopy. We observed and compared the incidence of hypoxia (75%≤SpO2 \\< 90% and \\< 60S), severe hypoxia (SpO2\\<75% for any duration or 75%≤SpO2 \\< 90%, ≥60s), subclinical respiratory depression (90%≤SpO2 \\< 95%), respiratory-related adverse events, sedation-related adverse events, and complications associated with high flow nasal cannula oxygenation using HFNC or regular nasal cannula during the sedated gastrointestinal endoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18≤ age ≤80, gender is not limited;\n2. Patients undergoing elective gastroenteroscopy or treatment;\n3. ASA grade Ⅲ\\~Ⅳ;\n4. 18 kg/m2≤BMI≤28kg/m2;\n5. The operation time of gastroenteroscopy is expected to be no more than 60min;\n6. Clearly understand, voluntarily participate in the study, and have informed consent from myself or my family members.\n\nExclusion Criteria:\n\n1. Patients with nasal congestion, nasal bleeding, recent nasal trauma, recent nasal surgery, increased intracranial pressure and skull fracture, etc., who can not perform high-flow nasal catheter oxygen;\n2. acute respiratory infections and asthma attacks;\n3. Patients diagnosed with COPD;\n4. Clear difficult airway;\n5. Acute upper gastrointestinal bleeding with shock;\n6. Gastrointestinal obstruction with gastric content retention;\n7. Allergic to sedatives such as propofol;\n8. Persons with no capacity for civil conduct such as cognitive dysfunction.'}, 'identificationModule': {'nctId': 'NCT07252102', 'briefTitle': 'Effect of High Flow Nasal Cannula Oxygenation on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients : A Multicentre Randomised Controlled Trial.', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Effect of High Flow Nasal Cannula Oxygenation on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients : A Multicentre Randomised Controlled Trial.', 'orgStudyIdInfo': {'id': 'ZJU2025C036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-flow nasal catheter oxygen', 'interventionNames': ['Device: High-flow nasal catheter oxygen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Regular nasal catheter oxygen', 'interventionNames': ['Device: regular nasal catheter oxygen']}], 'interventions': [{'name': 'High-flow nasal catheter oxygen', 'type': 'DEVICE', 'description': 'Before induction of anesthesia, connect the Airvo2 (HFNC high flow device) special nasal cannula to inhale oxygen, and preoxygenate with an oxygen flow rate of 6L /min. After induction of anesthesia, adjust the oxygen flow rate to 60L /min, oxygen concentration 100%, oxygen temperature 37℃ until the end of gastrointestinal endoscopy.', 'armGroupLabels': ['High-flow nasal catheter oxygen']}, {'name': 'regular nasal catheter oxygen', 'type': 'DEVICE', 'description': 'Before anesthesia induction, a disposable nasal catheter oxygen inhalation device (covered by HFNC nasal catheter and blinded to the patient) was connected to an oxygen source for pre-oxygen inhalation, 6L/min. After induction of anesthesia, oxygen was continued for 6L/min until the end of gastroenteroscopy.', 'armGroupLabels': ['Regular nasal catheter oxygen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '518116', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Quan Li', 'role': 'CONTACT', 'email': 'quanligene@126.com', 'phone': '+8618017187087'}], 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Diansan Su, Cheif of Anesthesiology Department, PhD', 'role': 'CONTACT', 'email': '184872238@qq.com', 'phone': '86+18616514088'}], 'facility': 'The First Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Diansan SU, Cheif of Anesthesiology Department, PhD', 'role': 'CONTACT', 'email': '184872238@qq.com', 'phone': '+8618616514088'}, {'name': 'Shuying Fu', 'role': 'CONTACT', 'email': '124045832@qq.com', 'phone': '+8613616619870'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Department of Anesthesiology, the First Affiliated Hospital of Zhejiang University School of Medicine', 'investigatorFullName': 'Diansan Su', 'investigatorAffiliation': 'Zhejiang University'}}}}