Effect of HFNC on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients

January 16, 2026 updated by: Diansan Su, Zhejiang University

Effect of High Flow Nasal Cannula Oxygenation on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients: A Multicentre Randomised Controlled Trial

High flow nasal cannula oxygenation (HFNC) offers high flow and concentration oxygen delivery, providing excellent non-respiratory oxygenation. As a relatively new oxygen delivery method, it has gained widespread use. We have demonstrated that high flow nasal cannula oxygenation reduce the incidence of hypoxia during sedated gastrointestinal endoscopy in patients with American Anesthesiologist Rating (ASA rating) grades 1 to 2 and obesity. We hypothesized that HFNC could mitigate the risk of hypoxia in critical patients during sedated gastrointestinal endoscopy. To confirm this, we selected critical patients with ASA grades 3 to 4 who were scheduled for gastrointestinal endoscopy. We observed and compared the incidence of hypoxia (75%≤SpO2 < 90% and < 60S), severe hypoxia (SpO2<75% for any duration or 75%≤SpO2 < 90%, ≥60s), subclinical respiratory depression (90%≤SpO2 < 95%), respiratory-related adverse events, sedation-related adverse events, and complications associated with high flow nasal cannula oxygenation using HFNC or regular nasal cannula during the sedated gastrointestinal endoscopy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Diansan SU, Cheif of Anesthesiology Department, PhD
  • Phone Number: +8618616514088
  • Email: 184872238@qq.com

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518000
        • Recruiting
        • Shenzhen Hospital of Southern Medical University
        • Contact:
      • Shenzhen, Guangdong, China, 518116
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences, ShenZhen center
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
          • Diansan Su, Cheif of Anesthesiology Department, PhD
          • Phone Number: 86+18616514088
          • Email: 184872238@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18≤ age ≤80, gender is not limited;
  2. Patients undergoing elective gastroenteroscopy or treatment;
  3. ASA grade Ⅲ~Ⅳ;
  4. 18 kg/m2≤BMI≤28kg/m2;
  5. The operation time of gastroenteroscopy is expected to be no more than 60min;
  6. Clearly understand, voluntarily participate in the study, and have informed consent from myself or my family members.

Exclusion Criteria:

  1. Patients with nasal congestion, nasal bleeding, recent nasal trauma, recent nasal surgery, increased intracranial pressure and skull fracture, etc., who can not perform high-flow nasal catheter oxygen;
  2. acute respiratory infections and asthma attacks;
  3. Patients diagnosed with COPD;
  4. Clear difficult airway;
  5. Acute upper gastrointestinal bleeding with shock;
  6. Gastrointestinal obstruction with gastric content retention;
  7. Allergic to sedatives such as propofol;
  8. Persons with no capacity for civil conduct such as cognitive dysfunction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-flow nasal catheter oxygen
Device: High-flow nasal catheter oxygen
Before induction of anesthesia, connect the Airvo2 (HFNC high flow device) special nasal cannula to inhale oxygen, and preoxygenate with an oxygen flow rate of 6L /min. After induction of anesthesia, adjust the oxygen flow rate to 60L /min, oxygen concentration 100%, oxygen temperature 37℃ until the end of gastrointestinal endoscopy.
Active Comparator: Regular nasal catheter oxygen
Device: regular nasal catheter oxygen
Before anesthesia induction, a disposable nasal catheter oxygen inhalation device (covered by HFNC nasal catheter and blinded to the patient) was connected to an oxygen source for pre-oxygen inhalation, 6L/min. After induction of anesthesia, oxygen was continued for 6L/min until the end of gastroenteroscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of hypoxia
Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
75%≤ SpO2 < 90% and < 60S
Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of severe hypoxia
Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
SpO2<75% for any duration, or 75%≤SpO2 < 90%, ≥60s
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Incidence of subclinical respiratory depression
Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
90%≤ SpO2<95%
Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2025

Primary Completion (Estimated)

December 28, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Estimated)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJU2025C036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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