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

NCT07155330 | Completed

• 1 other identifier: ZJU2025C128
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoxemia; Esophageal Cancer; Gastric Cancer (Diagnosis); Colon Cancer

Keywords

High-Flow Nasal Oxygen; Hypoxemia; Gastrointestinal Endoscopy; Sedation; obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• The incidence of hypoxia

  75% ≤ SpO2 \< 90% for \<60 s

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

Secondary Outcomes (2)

• The incidence of sub-clinical respiratory depression

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

• The incidence of severe hypoxia

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

Other Outcomes (1)

• The incidence of other adverse events

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

Study Arms (1)

High-flow nasal cannula

EXPERIMENTAL

Using high-flow nasal cannula oxygenation

Device: High-flow nasal cannula

Interventions

High-flow nasal cannula DEVICE

Using high-flow nasal cannula oxygenation

High-flow nasal cannula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Hypoxia; Esophageal Neoplasms; Stomach Neoplasms; Disease; Colonic Neoplasms; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician,Researcher

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: September 5, 2025
• Primary Completion: November 11, 2025
• Study Completion: November 11, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)