Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-02 @ 12:42 PM
Study NCT ID:
NCT06812403
Status:
COMPLETED
Last Update Posted:
2025-06-25
First Post:
2025-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination COMBO Endoscopy Oropharyngeal Airway With High-Flow Nasal Cannula Oxygenation in Sedated Gastrointestinal Endoscopy for Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D003111', 'term': 'Colonic Polyps'}], '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': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Combined use of the COMBO Endoscopy Oropharyngeal Airway with high-flow nasal Cannula Oxygenation in morbidly obese patients undergoing endoscopy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2025-02-01', 'studyFirstSubmitQcDate': '2025-02-01', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}}, '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 subclinical 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': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['The COMBO Endoscopy Oropharyngeal Airway', 'Hypoxia', 'High-flow nasal cannula Oxygenation', 'sedation', 'Gastrointestinal endoscopes'], 'conditions': ['Hypoxia', 'Esophageal Cancer', 'Gastric Cancer', 'Polyp of Colon']}, 'descriptionModule': {'briefSummary': 'Hypoxia is the most common adverse event during propofol sedation for gastrointestinal endoscopy, particularly in obese patients.\n\nA recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management.\n\nThis device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of this study is to evaluate the efficacy of the COMBO Endoscopy Oropharyngeal Airway in combination with High-Flow Nasal Cannula Oxygenation for reducing the incidence of hypoxia in obese patients undergoing gastrointestinal endoscopy under sedation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18≤ Age ≤70.\n* BMI ≥ 35 kg/m².\n* The ASA classification ranges from I to III.\n* Patients have signed the informed consent form.\n* Patients undergoing gastroendoscopy and colonoscopy procedure.\n* The estimated duration of the procedure does not exceed 45 minutes.\n\nExclusion Criteria:\n\n* Patients who exhibit contraindications to oropharyngeal airway ventilation, such as coagulation disorders, a predisposition to oral and nasal bleeding, mucosal damage, or anatomical constraints impeding oropharyngeal channel placement.\n* Severe cardiac insufficiency, defined as a maximal exercise capacity of less than 4 metabolic equivalents (METs).\n* Profound renal insufficiency necessitating preoperative dialysis.\n* A confirmed severe liver dysfunction.\n* Patients diagnosed with chronic obstructive pulmonary disease (COPD) or those presently experiencing other acute and chronic pulmonary conditions necessitating prolonged or intermittent oxygen therapy.\n* Elevated intracranial pressure.\n* Upper respiratory tract infections, encompassing the oral, nasal, and pharyngeal regions.\n* Fever, defined as a core body temperature exceeding 37.5 degrees Celsius.\n* Pregnancy or lactation.\n* Hypersensitivity reactions to sedatives like propofol or medical equipment such as adhesive tape.\n* Urgent surgical intervention.\n* Polytrauma.\n* Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively.\n* BMI\\<35 kg/m².\n* Patients with a documented history of substance abuse, specifically drugs and/or alcohol, within the two years preceding the commencement of the screening period. Substance abuse in this context is defined as consuming more than three standard alcoholic beverages daily, roughly equivalent to 10g of alcohol or 50g of Chinese Baijiu.\n* Patients with a history of mental and neurological disorders, including but not limited to depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease, and myasthenia gravis.\n* Presently engaged in concurrent participation in additional clinical trials.\n* Patients considered ineligible by researchers for inclusion in this clinical trial."}, 'identificationModule': {'nctId': 'NCT06812403', 'briefTitle': 'Combination COMBO Endoscopy Oropharyngeal Airway With High-Flow Nasal Cannula Oxygenation in Sedated Gastrointestinal Endoscopy for Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Combination COMBO Endoscopy Oropharyngeal Airway With High-Flow Nasal Cannula Oxygenation in Sedated Gastrointestinal Endoscopy for Obese Patients', 'orgStudyIdInfo': {'id': 'ZJU2025C018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation', 'description': 'In this group, patients use the COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation.', 'interventionNames': ['Device: the COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation']}], 'interventions': [{'name': 'the COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation', 'type': 'DEVICE', 'description': 'Using the COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation in Sedated Gastrointestinal Endoscopy for Obese Patients', 'armGroupLabels': ['the COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair of the Department of Anesthesiology', 'investigatorFullName': 'Diansan Su', 'investigatorAffiliation': 'Zhejiang University'}}}}