High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients
NCT07307560
Summary
Hypoxia represents the most frequent adverse event during propofol-sedated gastrointestinal endoscopy. The STOP-BANG questionnaire serves as a widely adopted, straightforward tool for screening obstructive sleep apnea (OSA) risk, with a score ≥5 identifying high-risk OSA patients who are particularly susceptible to hypoxia under sedation. Although preliminary research from our team suggests that High-Flow Nasal Cannula (HFNC) may lower the incidence of hypoxemia, evidence remains limited and inconsistent in studies specifically targeting high-risk OSA populations. Therefore, this multicenter randomized controlled trial aims to evaluate whether HFNC can effectively reduce the occurrence of hypoxia during sedated gastrointestinal endoscopy in patients identified as high-risk for OSA.
Eligibility
Inclusion Criteria: * Age ≥18 years. * STOP-Bang score ≥5. * Scheduled for sedated gastrointestinal endoscopy (gastroscopy, colonoscopy, or combined gastroscopy + colonoscopy). * The estimated duration of the procedure does not exceed 45 minutes. * Patients have signed the informed consent form. Exclusion Criteria: * Coagulation disorders or bleeding tendency (e.g., oral/nasal bleeding risk, mucosal injury, space-occupying obstructions). * Active upper respiratory tract infection (oral, nasal, or pharyngeal), or fever (core temperature \>37.5°C). * Chronic obstructive pulmonary disease or other acute/chronic pulmonary diseases requiring long-term or intermittent oxygen therapy, or preoperative SpO₂ ≤ 92% on room air. * Severe organ dysfunction, including: Cardiac insufficiency (\<4 METs), Severe renal insufficiency (requiring dialysis), Diagnosed severe hepatic insufficiency, Increased intracranial pressure, ASA physical status ≥ IV. * Confirmed pregnancy or current breastfeeding. * Known allergy to sedatives (e.g., propofol) or medical adhesives. * Multiple traumatic injuries. * Current participation in another clinical trial. * Other conditions deemed unsuitable by the investigator
Conditions5
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NCT07307560