Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-05-02 @ 7:28 PM
Study NCT ID:
NCT03332433
Status:
COMPLETED
Last Update Posted:
2018-09-05
First Post:
2017-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol
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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2034}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-02', 'studyFirstSubmitDate': '2017-10-26', 'studyFirstSubmitQcDate': '2017-11-01', 'lastUpdatePostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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': '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': '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', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average of 2 hours', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypoxia', 'Gastroscope', 'High-flow nasal cannula'], 'conditions': ['Hypoxia', 'Gastric Cancer', 'Esophagus Cancer', 'Adverse Event']}, 'referencesModule': {'references': [{'pmid': '31278907', 'type': 'DERIVED', 'citation': 'Lin Y, Zhang X, Li L, Wei M, Zhao B, Wang X, Pan Z, Tian J, Yu W, Su D. High-flow nasal cannula oxygen therapy and hypoxia during gastroscopy with propofol sedation: a randomized multicenter clinical trial. Gastrointest Endosc. 2019 Oct;90(4):591-601. doi: 10.1016/j.gie.2019.06.033. Epub 2019 Jul 3.'}]}, 'descriptionModule': {'briefSummary': 'Hypoxia is the most common adverse events during sedated gastroscopy. In present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the hypoxia. At the same time the feasibility and safety will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing gastroscope\n* age over 18 years old\n* Signed informed consent form\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 hemodynamic 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 \\>III;\n* Mouth, nose, or throat infection;\n* Fever, defined as core body temperature \\> 37.5oC ;\n* Pregnancy, breastfeeding or positive pregnancy test\n* Emergency procedure'}, 'identificationModule': {'nctId': 'NCT03332433', 'acronym': 'HONCHO', 'briefTitle': 'High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol: a Randomized Multicentre Clinical Trial', 'orgStudyIdInfo': {'id': 'RenJiH-20170724'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Oxygen(2L/min) supplied with nasal catheter'}, {'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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200065', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Tongji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Renji hospital, School of Medicine, Shanghai Jiaotong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai Pudong New Area People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "Shanghai Pudong New Area People's Hospital", 'class': 'OTHER'}, {'name': 'Shanghai Tongji Hospital, Tongji University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Chair of the Department of Anesthesiology', 'investigatorFullName': 'diansan su', 'investigatorAffiliation': 'RenJi Hospital'}}}}