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NCT07623863
Multifunctional Oropharyngeal Airway and Hypoxemia in Sedated GI Endoscopy: A Multicenter RCT
Conditions: Hypoxemia, Airway Management
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 1518
Sponsor: Qianfoshan Hospital
Summary
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 \< 90% for \
Eligibility Criteria
Inclusion Criteria:
* Age 18-80 years;
* BMI: 18-30 kg/m²;
* ASA class I-II;
* Scheduled to undergo elective sedated gastrointestinal endoscopy;
* Willing to participate in this study and able to provide written informed consent.
Exclusion Criteria:
* 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.;
* Coagulation disorders, tendency for oral/nasal bleeding, mucosal injury, or space-occupying lesions;
* Severe cardiac insufficiency (≤4 MetS);
* Severe renal insufficiency (acute kidney injury \[AKI\] or chronic kidney disease \[CKD\] stage 4 or higher);
* Severe hepatic insufficiency (Child-Pugh class C or worse);
* Planned therapeutic endoscopy (e.g., polypectomy, endoscopic mucosal resection \[EMR\], or other therapeutic procedures);
* Pregnancy or breastfeeding;
* Allergy to the study drugs;
* Emergency surgery;
* Daily alcohol intake ≥60 grams;
* History of psychiatric disorders: e.g., depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease;
* Myasthenia gravis;
* Participation in other related clinical trials within the past 3 months;
* Refusal to participate.
Source: ClinicalTrials.gov (NCT07623863). StuddyBuddy aggregates publicly available trial information.
