Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07307560

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

Led by Zhejiang University · Updated on 2026-05-04

600

Participants Needed

3

Research Sites

49 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • STOP-Bang score 5 or higher
  • Scheduled for sedated gastrointestinal endoscopy (gastroscopy, colonoscopy, or combined gastroscopy and colonoscopy)
  • Procedure expected to last no more than 45 minutes
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Coagulation disorders or bleeding tendency, including risk of oral or nasal bleeding and mucosal injury
  • Active upper respiratory tract infection or fever with core temperature above 37.5C
  • Chronic obstructive pulmonary disease or other pulmonary diseases requiring oxygen therapy, or preoperative oxygen saturation (SpO2) 92% or less on room air
  • Severe organ dysfunction including cardiac insufficiency with less than 4 METs, severe renal insufficiency requiring dialysis, severe hepatic insufficiency, increased intracranial pressure, or ASA physical status class IV or higher
  • Confirmed pregnancy or currently breastfeeding
  • Known allergy to sedatives such as propofol or to medical adhesives
  • Multiple traumatic injuries
  • Current participation in another clinical trial
  • Other conditions judged unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

2

The First Hospital Of Jiaxing

Jiaxing, Zhejiang, China, 314000

Actively Recruiting

3

Quzhou People's Hospital

Quzhou, Zhejiang, China, 324000

Actively Recruiting

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Research Team

D

Diansan Su, Chief Physician

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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