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NCT07307560Recruiting

High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients

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

Source: ClinicalTrials.gov · Last updated 4 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
600 (estimated)
First submitted
14 Dec 2025
Start date
21 Dec 2025
Primary completion date
1 Dec 2026
Lead sponsor
Zhejiang University
NCT number
NCT07307560

What you commit to

  • Study type: Interventional
  • Planned participants: 600
  • From 21 Dec 2025 to the primary completion date, 1 Dec 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.
  • Known allergy to sedatives (e.g., propofol) or medical adhesives.
  • Other conditions deemed unsuitable by the investigator

Other

  • Confirmed pregnancy or current breastfeeding.
  • Multiple traumatic injuries.
  • Current participation in another clinical trial.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital Zhejiang University School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
The First Hospital Of Jiaxing
Coordinator of this site? Confirm its status
JiaxingChinaRecruiting
Quzhou people's Hospital
Coordinator of this site? Confirm its status
QuzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.