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High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients: A Multicenter Randomized Trial

NCT ID: NCT07307560

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-21

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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Sedation Hypoxia Obstructive Sleep Apnea (OSA) Gastrointestinal Endoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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High-flow nasal cannula Group

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

Group Type EXPERIMENTAL

High-flow nasal cannula Group

Intervention Type DEVICE

Using High-flow nasal cannula oxygenation

Regular Nasal Cannula Group

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

Group Type ACTIVE_COMPARATOR

Regular Nasal Cannula

Intervention Type DEVICE

Using regular nasal cannula for oxygenation

Interventions

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High-flow nasal cannula Group

Using High-flow nasal cannula oxygenation

Intervention Type DEVICE

Regular Nasal Cannula

Using regular nasal cannula for oxygenation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Diansan Su

Chief Physician,Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

The First Hospital Of Jiaxing

Jiaxing, Zhejiang, China

Site Status

Quzhou People's Hospital

Quzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Diansan Su, Chief Physician

Role: CONTACT

Phone: +8618616514088

Email: [email protected]

Facility Contacts

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Diansan Su, Dr

Role: primary

Huadong Ni, Dr

Role: primary

Huiling Yu, Dr

Role: primary

Other Identifiers

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ZJU2025C207

Identifier Type: -

Identifier Source: org_study_id