High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- High-flow nasal cannula Group
- Regular Nasal Cannula
Treatment groups
600 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov