High-flow nasal oxygen to prevent low oxygen during sedated endoscopy in people with high-risk sleep apnea

High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients: A Multicenter Randomized Trial

This will test whether using high‑flow nasal oxygen instead of a regular nasal cannula prevents low oxygen levels during propofol‑sedated gastroscopy or colonoscopy in adults with high‑risk obstructive sleep apnea (STOP‑Bang ≥5).

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhejiang University (Academic / other)
• Locations: 3 sites (Hangzhou, Zhejiang and 2 other locations)
• Trial ID: NCT07307560 on ClinicalTrials.gov

What this trial studies

This multicenter randomized controlled trial compares high‑flow nasal cannula (HFNC) with standard nasal cannula during propofol‑sedated gastrointestinal endoscopy in adults identified as high risk for OSA (STOP‑Bang ≥5). Eligible patients scheduled for gastroscopy, colonoscopy, or both, with procedures expected to last 45 minutes or less, will be randomized to receive HFNC or regular nasal oxygen during the procedure. The primary outcome is the occurrence of hypoxia (oxygen desaturation) during the procedure, with safety and adverse events also recorded. Major exclusions include active upper respiratory infection, chronic pulmonary disease requiring long‑term oxygen, preoperative SpO2 ≤92% on room air, severe organ dysfunction, coagulation disorders, pregnancy, or breastfeeding.

Who should consider this trial

Good fit: Adults aged 18 or older with STOP‑Bang ≥5 who are scheduled for a propofol‑sedated gastroscopy or colonoscopy expected to last 45 minutes or less and who can give informed consent.

Not a fit: Patients with chronic lung disease requiring long‑term oxygen, preoperative SpO2 ≤92% on room air, severe organ dysfunction, active upper respiratory infection, bleeding risk, or those who are pregnant or breastfeeding are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, HFNC could reduce episodes of oxygen desaturation during sedated endoscopy, making procedures safer for high‑risk OSA patients.

How similar studies have performed: Previous small or preliminary studies suggest HFNC can reduce hypoxemia during sedation, but evidence is limited and inconsistent specifically in high‑risk OSA populations.

Eligibility criteria

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

Where this trial is running

Hangzhou, Zhejiang and 2 other locations

• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• The First Hospital Of Jiaxing — Jiaxing, Zhejiang, China (Recruiting)
• Quzhou People's Hospital — Quzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Diansan Su, Chief Physician

Conditions Hypoxia; Esophageal Cancer; Gastric Cancer; Obstructive Sleep Apnea; Sedation; Gastrointestinal Endoscopy