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NCT Number: NCT07155330

High-flow Nasal Cannula Oxygenation in Sedated Endoscopy for High-risk Obstructive Sleep Apnea Patients

Hypoxia is the most common adverse event during propofol sedation for gastrointestinal endoscopy. The STOP-BANG questionnaire is a widely used, simple assessment tool for screening obstructive sleep apnea (OSA) risk. A STOP-Bang score ≥5 indicates high-risk OSA patients who are more prone to hypoxia during sedated endoscopy. Our team's preliminary clinical research found that High-Flow Nasal Cannula (HFNC) may reduce hypoxemia risk, but there are limited dedicated studies focusing specifically on high-risk OSA patients, with controversial results. This study aims to investigate whether HFNC can reduce the incidence of hypoxia during sedated gastrointestinal endoscopy in high-risk obstructive sleep apnea patients.

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Key information

Conditions

Hypoxemia Apnea Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Dyssomnias Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastric Cancer (Diagnosis) Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Hypoxia Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-flow nasal cannula

Device

Using high-flow nasal cannula oxygenation

Primary outcomes

  1. The incidence of hypoxia

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    75% ≤ SpO2 < 90% for <60 s

Secondary outcomes

  1. The incidence of sub-clinical respiratory depression

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    90% ≤ SpO2 < 95%

  2. The incidence of severe hypoxia

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s

Other outcomes

  1. The incidence of other adverse events

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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