RecruitingNot ApplicableNCT07307560

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

Sponsor

Zhejiang University

Enrollment

600 participants

Start Date

Dec 21, 2025

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer Hypoxia Gastric Cancer (Diagnosis)Obstructive Sleep Apnea (OSA)

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria9

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