[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639566":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":18,"responsibleParty":40,"collaborators":18,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":18,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":18,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":68,"whyStopped":18,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":18},{"fullName":5,"class":6},"Qianfoshan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group: Novel multifunctional oropharyngeal airway group","EXPERIMENTAL","Before anesthesia, oxygen is administered via nasal cannula at 3-4 L\u002Fmin, and the dedicated mouthpiece of the novel multifunctional oropharyngeal airway is inserted. After anesthesia induction and before gastroscope insertion, the anesthesiologist places the novel multifunctional oropharyngeal airway through the side of the mouthpiece and connects the oxygen supply device of the airway to deliver oxygen. The PETCO₂ sampling port of the airway is connected to the monitor to achieve continuous real-time end-tidal carbon dioxide monitoring. Insertion and fixation of the airway are completed under sedation to avoid patient discomfort.",[13],"Device: Novel Multifunctional Oropharyngeal Airway",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group: Conventional mouthpiece group","NO_INTERVENTION","Before anesthesia, oxygen is administered via nasal cannula at 3-4 L\u002Fmin, and a conventional mouthpiece is inserted. The PETCO₂ sampling port of the nasal cannula is connected to the monitor to achieve continuous real-time end-tidal carbon dioxide monitoring. After anesthesia induction, the gastroscopy is completed without using an oropharyngeal airway.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Novel Multifunctional Oropharyngeal Airway","The Novel Multifunctional Oropharyngeal Airway is an integrated airway device designed for sedated gastrointestinal endoscopy. It combines a modified mouthpiece, an oropharyngeal airway, an oxygen delivery channel, and a PETCO₂ sampling port into a single unit. The device maintains upper airway patency by preventing tongue prolapse, delivers oxygen directly to the pharynx near the glottis for more efficient oxygenation, and enables continuous real-time capnography monitoring. It is made of soft medical-grade material with anatomical curvature and depth markings to minimize mucosal injury and patient discomfort. The MOPA also reserves an interface for emergency jet ventilation if needed. It is inserted under sedation and allows the endoscope to pass smoothly through its central channel without obstruction.",[9],[26],{"name":27,"affiliation":28,"role":29},"Jianbo Wu, Doctoral","Shandong First Medical University","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"jianbo wu","CONTACT","18560083793","jianbowu@sdu.edu.cn",{"name":37,"role":33,"phone":38,"phoneExt":18,"email":39},"琦 尤","19553100910","312011097@qq.com",{"type":41,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100639566","multifunctional-oropharyngeal-airway-and-hypoxemia-in-sedated-gi-endoscopy-a-multicenter-rct-100639566",false,"NCT07623863","Multifunctional Oropharyngeal Airway and Hypoxemia in Sedated GI Endoscopy: A Multicenter RCT","Effect of a Novel Multifunctional Oropharyngeal Airway on Hypoxemia in Patients Undergoing Sedated Gastrointestinal Endoscopy: A Multicenter, Prospective, Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18-80 years;\n* BMI: 18-30 kg\u002Fm²;\n* ASA class I-II;\n* Scheduled to undergo elective sedated gastrointestinal endoscopy;\n* Willing to participate in this study and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Diagnosed respiratory diseases, including asthma, bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, moderate or severe obstructive sleep apnea (OSA), pulmonary embolism, pulmonary edema, lung cancer, or upper respiratory tract infection, etc.;\n* Coagulation disorders, tendency for oral\u002Fnasal bleeding, mucosal injury, or space-occupying lesions;\n* Severe cardiac insufficiency (≤4 MetS);\n* Severe renal insufficiency (acute kidney injury \\[AKI\\] or chronic kidney disease \\[CKD\\] stage 4 or higher);\n* Severe hepatic insufficiency (Child-Pugh class C or worse);\n* Planned therapeutic endoscopy (e.g., polypectomy, endoscopic mucosal resection \\[EMR\\], or other therapeutic procedures);\n* Pregnancy or breastfeeding;\n* Allergy to the study drugs;\n* Emergency surgery;\n* Daily alcohol intake ≥60 grams;\n* History of psychiatric disorders: e.g., depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease;\n* Myasthenia gravis;\n* Participation in other related clinical trials within the past 3 months;\n* Refusal to participate.",true,"ALL","18 Years","80 Years",{"count":54,"type":55},1518,"ESTIMATED","INTERVENTIONAL",[58],"NA","This multicenter, prospective, randomized controlled trial aims to evaluate whether a novel multifunctional oropharyngeal airway (MOPA) reduces the incidence of hypoxemia in 1,518 adult patients (ASA I-II, aged 18-80 years) undergoing elective sedated gastrointestinal endoscopy. Patients are randomized 1:1 to receive either the MOPA (which integrates oxygen delivery, PETCO₂ monitoring, and airway support) or conventional nasal cannula with standard mouthpiece. The primary endpoint is the incidence of hypoxemia (75% ≤ SpO₂ \\\u003C 90% for \\\u003C60 seconds) during the procedure. Secondary outcomes include severe hypoxemia, hypercapnia, PETCO₂ monitoring success, airway interventions, adverse events, and satisfaction scores. The study is conducted across 29 centers in China, with centralized randomization via an EDC system, blinded outcome assessment, and statistical analysis using a two-sided alpha of 0.05 (power 90%). Results are expected to provide high-level evidence for optimizing airway management during sedated endoscopy.",[61,62],"Hypoxemia","Airway Management",[64,65,66,67],"Novel multifunctional oropharyngeal airway","Capnography \u002F PETCO₂ monitoring","Airway management","Randomized controlled trial","NOT_YET_RECRUITING","2026-05-28",{"date":71,"type":72},"2026-06-03","ACTUAL",{"date":74,"type":55},"2026-06-01",{"date":76,"type":55},"2028-06-01",{"name":5,"class":6}]