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Clinical Trials in China / NCT07307560
Recruiting Not applicable

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

NCT07307560 · tracked via the Priya Life Science China tracker
Sponsor
Zhejiang University
Phase
Not applicable
Started
2025-12-21
Last updated
2026-05-04

Condition(s) studied

HypoxiaEsophageal CancerGastric Cancer (Diagnosis)Obstructive Sleep Apnea (OSA)

Investigational drug(s) / intervention(s)

High-flow nasal cannula GroupRegular Nasal Cannula

High-flow nasal cannula Group: Using High-flow nasal cannula oxygenation

Regular Nasal Cannula: Using regular nasal cannula for oxygenation

Study summary

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting
The First Hospital Of Jiaxing Jiaxing Zhejiang Recruiting
Quzhou People's Hospital Quzhou Zhejiang Recruiting

More Zhejiang University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07307560 on ClinicalTrials.gov ↗ ← All trials in China