Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-27 @ 4:45 AM
Study NCT ID:
NCT04500392
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2020-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D003111', 'term': 'Colonic Polyps'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], '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': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-09', 'studyFirstSubmitDate': '2020-08-02', 'studyFirstSubmitQcDate': '2020-08-02', 'lastUpdatePostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of hypoxia', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average of 2 hours]', 'description': '(75% ≤ SpO2 \\< 90% for \\<60 s)'}], 'secondaryOutcomes': [{'measure': 'The incidence of subclinical respiratory depression', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average of 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 of 2 hours', 'description': '(SpO2 \\< 75% for any duration or 75% \\< SpO2 \\< 90% for \\>/=60 s)'}, {'measure': 'Other adverse events include other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events.', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average of 2 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypoxia', 'Gastrointestinal endoscopes', 'High-flow nasal cannula Oxygenation'], 'conditions': ['Hypoxia', 'Gastric Cancer', 'Esophagus Cancer', 'Polyp of Colon', 'Colon Cancer']}, 'referencesModule': {'references': [{'pmid': '39933757', 'type': 'DERIVED', 'citation': 'Wang L, Zhang Y, Han D, Wei M, Zhang J, Cheng X, Zhang Y, Shi M, Song Z, Wang X, Zhang X, Su D. Effect of high flow nasal cannula oxygenation on incidence of hypoxia during sedated gastrointestinal endoscopy in patients with obesity: multicentre randomised controlled trial. BMJ. 2025 Feb 11;388:e080795. doi: 10.1136/bmj-2024-080795.'}]}, 'descriptionModule': {'briefSummary': 'Hypoxia is the most common adverse event during gastrointestinal endoscopes sedated with propofol and sufentanil, especially in obese people. In the present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the incidence of hypoxia among obesity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing gastrointestinal endoscopes\n* age≥18 years old and ≤70 years old\n* patients or family members signed informed consent form\n* ASA classification I-II\n* BMI≥ 28kg/m²\n\nExclusion Criteria:\n\n* Coagulation disorders or a tendency of nose bleeding;\n* An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months;\n* Severe aortic stenosis or mitral stenosis;\n* Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months;\n* Acute myocardial infarction in the last 6 months;\n* Acute arrhythmia (including any tachycardia - or bradycardia) with the fluid of hemodynamics instability;\n* Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy);\n* Increased intracranial pressure;\n* ASA classification Ⅲ-Ⅳ ;\n* Mouth, nose, or throat infection;\n* Liver and kidney disease\n* Fever, defined as core body temperature \\> 37.5℃;\n* Pregnancy, breastfeeding or positive pregnancy test;\n* Emergency procedure;\n* Patients or family members refused to participate\n* Mental disorders and people without civil capacity'}, 'identificationModule': {'nctId': 'NCT04500392', 'briefTitle': 'High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity: a Randomized Multicenter Clinical Trial', 'orgStudyIdInfo': {'id': 'HFNOIO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Oxygen(up to 6L/min) supplied with a regular nasal catheter', 'interventionNames': ['Device: Regular nasal cannula']}, {'type': 'EXPERIMENTAL', 'label': 'High-flow nasal cannula group', 'description': 'Oxygen(up to 60L/min) supplied with high-flow nasal cannula', 'interventionNames': ['Device: High-flow nasal cannula oxygenation']}], 'interventions': [{'name': 'High-flow nasal cannula oxygenation', 'type': 'DEVICE', 'description': 'Oxygen is supplied with a high-flow nasal cannula oxygenation device#the flow is up to 60L/min', 'armGroupLabels': ['High-flow nasal cannula group']}, {'name': 'Regular nasal cannula', 'type': 'DEVICE', 'description': 'Oxygen is supplied with a regular nasal cannula #the flow is up to 6L/min', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200065', 'city': 'Shanghai', 'state': 'Shanghai, China', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoqing Zhang, M.S.', 'role': 'CONTACT', 'email': 'xq_820175@163.com'}], 'facility': 'Shanghai Tongji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200120', 'city': 'Shanghai', 'state': 'Shanghai, China', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangrui Wang, Dr.', 'role': 'CONTACT', 'email': 'wangxr2010@yahoo.com'}], 'facility': 'Shanghai Oriental Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai, China', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhang Yuanyuan, B.S.', 'role': 'CONTACT', 'email': '2630643807@qq.com', 'phone': '+862168383702'}], 'facility': 'Renji hospital, School of Medicine, Shanghai Jiaotong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Diansan Su, Dr.', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '+862168383702'}], 'overallOfficials': [{'name': 'Diansan Su, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Renji Hospital, Shanghai Jiaotong University, Shanghai, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Tongji Hospital, Tongji University School of Medicine', 'class': 'OTHER'}, {'name': 'Shanghai Oriental Hospital, Tongji University School of Medicine', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Chair of the Department of Anesthesiology', 'investigatorFullName': 'diansan su', 'investigatorAffiliation': 'RenJi Hospital'}}}}