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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: diansansu@yahoo.com
• Phone: +8618616514088

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.