[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593925":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":54,"collaborators":20,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":20,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":20,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":78,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"The COMBO Endoscopy Oropharyngeal Airway Group","EXPERIMENTAL","In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation.",[13],"Device: The COMBO Endoscopy Oropharyngeal Airway",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","The COMBO Endoscopy Oropharyngeal Airway","Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"DiSan Head of Anesthesiology, PhD","CONTACT","86+18616514088","184872238@qq.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Lianjuan Sun, Master","+8618257152767","sunlianjuan26@163.com",[32,49],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"he First Affiliated Hospital, Zhejiang University School of Medicine","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":41,"coordinates":42},"Point",[43,44],120.16142,30.29365,{"lat":44,"lon":43},[47],{"name":48,"role":24,"phone":25,"phoneExt":20,"email":26},"DiSan Diansan Su, PhD",{"facility":50,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":51,"geoPoint":53,"contacts":20},"The First Affiliated Hospital,Zhejiang University School of Medicine",{"type":41,"coordinates":52},[43,44],{"lat":44,"lon":43},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Diansan Su","Chair of the Department of Anesthesiology","100593925","phase-2-combo-endoscopy-oropharyngeal-airway-in-sedated-endoscopic-retrograde-cholangiopancreatography-for-patients-100593925",false,"NCT07012772","COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients","Inclusion Criteria:\n\n* Age ≥18 years；\n* The ASA classification ranges from I to III.\n* Patients have signed the informed consent form.\n* Patients scheduled to undergo sedated ERCP examination;\n* The estimated duration of the procedure does not exceed 45 minutes.\n\nExclusion Criteria:\n\n1. Patients with coagulation disorders, tendency for oral\u002Fnasal bleeding, mucosal injury\u002Foccupying lesions, or difficult oropharyngeal airway insertion making airway management unfeasible;\n2. Severe cardiac dysfunction (\\\u003C4 METs);\n3. Severe renal insufficiency (requiring preoperative dialysis);\n4. Child-Pugh class C;\n5. Diagnosed chronic obstructive pulmonary disease (COPD) or other acute\u002Fchronic pulmonary diseases requiring long-term\u002Fintermittent oxygen therapy;\n6. Increased intracranial pressure;\n7. Upper respiratory tract infections (oral\u002Fnasal\u002Fpharyngeal);\n8. Fever (core temperature \\>37.5°C);\n9. Confirmed pregnancy or current breastfeeding;\n10. Allergy to sedatives (e.g., propofol) or medical adhesives;\n11. Emergency procedures;\n12. Multiple trauma injuries;\n13. Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively;\n14. BMI \\\u003C18.5 or \\>30 kg\u002Fm²;\n15. Current participation in other clinical trials;\n16. Other conditions deemed ineligible by investigators.","ALL","18 Years",{"count":67,"type":68},50,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) with propofol. 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. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of this study is to assess the efficacy of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in patients undergoing ERCP under sedation.",[74,75,76,77],"Choledocholithiasis With Cholecystitis With Obstruction","Obstructive Jaundice","Pancreatitis","Cholelithiasis",[79,17,80,81,82],"respiratory depression","Hypoxia","Sedation","ERCP","2025-06-23",{"date":85,"type":86},"2025-06-24","ACTUAL",{"date":88,"type":86},"2025-06-12",{"date":90,"type":68},"2025-12-31",{"name":5,"class":6},2]