[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606407":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":112,"collaborators":25,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":25,"eligibilityCriteria":122,"healthyVolunteers":118,"sex":123,"minAge":124,"maxAge":25,"enrollmentInfo":125,"targetDuration":25,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":137,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation","EXPERIMENTAL","In this group, patients use the COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation",[13],"Device: COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation",{"label":15,"type":16,"description":17,"interventionNames":18},"High-Flow Nasal Cannula Oxygenation","ACTIVE_COMPARATOR","In this group, patients use the High-Flow Nasal Cannula Oxygenation",[19],"Device: High-Flow Nasal Cannula Oxygenation",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Using the COMBO endoscopy oropharyngeal airway with High-Flow Nasal Cannula Oxygenation in sedated gastrointestinal endoscopy for morbidly obese patients",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"In this group, patients use high-flow nasal cannula oxygenation",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Diansan Su, Chief Physician","CONTACT","+8618616514088","diansansu@yahoo.com",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Mingxia Xu","+8613516713435","xumingxia@zju.edu.cn",[40,58,73,86,99],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Peking University First Hospital","RECRUITING","Beijing","Beijing Municipality","100000","China","CN",{"type":49,"coordinates":50},"Point",[51,52],116.39723,39.9075,{"lat":52,"lon":51},[55],{"name":56,"role":32,"phone":25,"phoneExt":25,"email":57},"Dongxin Wang, Dr","dxwang65@bjmu.edu.cn",{"facility":59,"status":42,"city":60,"state":61,"zip":62,"country":46,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Jinjiang Municipal Hospital","Jinjiang","Fujian","362200",{"type":49,"coordinates":64},[65,66],118.57415,24.81978,{"lat":66,"lon":65},[69],{"name":70,"role":32,"phone":71,"phoneExt":25,"email":72},"Fusheng Xu, Dr","+86 13860742856","936612081@qq.com",{"facility":74,"status":42,"city":75,"state":76,"zip":77,"country":46,"countryCode":47,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"The First Affiliated Hospital, Zhejiang University School of Medicine","Hangzhou","Zhejiang","310000",{"type":49,"coordinates":79},[80,81],120.16142,30.29365,{"lat":81,"lon":80},[84],{"name":85,"role":32,"phone":33,"phoneExt":25,"email":34},"Diansan Su, Dr",{"facility":87,"status":42,"city":88,"state":76,"zip":77,"country":46,"countryCode":47,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"The Fifth Affiliated Hospital of Wenzhou Medical University","Lishui",{"type":49,"coordinates":90},[91,92],119.91029,28.46042,{"lat":92,"lon":91},[95],{"name":96,"role":32,"phone":97,"phoneExt":25,"email":98},"Zhilan Dou","+8618857809608","1024734445@qq.com",{"facility":100,"status":42,"city":101,"state":76,"zip":77,"country":46,"countryCode":47,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Taizhou Hospital of Zhejiang Province","Taizhou",{"type":49,"coordinates":103},[104,105],121.43312,28.66266,{"lat":105,"lon":104},[108],{"name":109,"role":32,"phone":110,"phoneExt":25,"email":111},"Lijun Zhu","+8613586117093","zhulijun@enzemed.com",{"type":113,"investigatorFullName":114,"investigatorTitle":115,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Diansan Su","Chief Physician,Researcher","100606407","combination-of-combo-endoscopy-oropharyngeal-airway-and-hfnc-oxygenation-in-sedated-gastrointestinal-endoscopy-for-morbidly-obese-patients-100606407",false,"NCT07175155","Combination of COMBO Endoscopy Oropharyngeal Airway and HFNC Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients","Combination of COMBO Endoscopy Oropharyngeal Airway and High-flow Nasal Cannula Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients: a Multicenter, Randomized, Controlled Clinical Trial","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* BMI ≥ 35 kg\u002Fm².\n* Patients undergoing gastroscopy or gastrointestinal endoscopy.\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\u002Fnasal bleeding risk, mucosal injury, oropharyngeal obstruction) making oropharyngeal airway placement unsafe or unfeasible.\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\u002Fchronic pulmonary diseases requiring long-term or intermittent oxygen therapy, or preoperative SpO₂ ≤ 92% on room air.\n* Severe organ dysfunction, including: Cardiac insufficiency (\\\u003C4 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.","ALL","18 Years",{"count":126,"type":127},410,"ESTIMATED","INTERVENTIONAL",[130],"NA","Hypoxaemia during sedated gastrointestinal endoscopy exceeds 40 % in morbidly obese (BMI ≥ 35 kg m-²) patients. High-flow nasal cannula alone often fails because of persistent airway collapse. A 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.The purpose of this study is to investigate whether the combination of the COMBO Endoscopy Oropharyngeal Airway and High-Flow Nasal Cannula oxygenation reduces the incidence of hypoxemia in this population.",[133,134,135,136],"Hypoxemia","Esophageal Cancer","Morbidly Obese Patients","Gastric Cancer",[138,133,139,140,141],"COMBO Endoscopy Oropharyngeal Airway","Sedation","Gastrointestinal Endoscopy","high-flow nasal cannula","2026-03-09",{"date":144,"type":145},"2026-03-11","ACTUAL",{"date":147,"type":145},"2025-10-24",{"date":149,"type":127},"2027-08-20",{"name":5,"class":6},5]