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

NCT07307560 | Recruiting

• 1 other identifier: ZJU2025C207
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

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

Keywords

Sedation; Hypoxia; Obstructive Sleep Apnea (OSA); Gastrointestinal Endoscopy

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 (2)

High-flow nasal cannula Group

EXPERIMENTAL

In this group, patients use the High-flow nasal cannula

Device: High-flow nasal cannula Group

Regular Nasal Cannula Group

ACTIVE COMPARATOR

In this group, patients use the regular nasal cannula for oxygenation.

Device: Regular Nasal Cannula

Interventions

High-flow nasal cannula Group DEVICE

Using High-flow nasal cannula oxygenation

High-flow nasal cannula Group

Regular Nasal Cannula DEVICE

Using regular nasal cannula for oxygenation

Regular Nasal Cannula Group

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 (3)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

The First Hospital Of Jiaxing

Jiaxing, Zhejiang, 314000, China

RECRUITING

Quzhou People's Hospital

Quzhou, Zhejiang, 324000, China

RECRUITING

MeSH Terms

Conditions

Hypoxia; Esophageal Neoplasms; Stomach Neoplasms; Disease; 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; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Diansan Su, Chief Physician

CONTACT

+8618616514088; diansansu@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician,Researcher

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 29, 2025
• Study Start: December 21, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2025-12

Locations

CN (3)