Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07252102

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

Led by Zhejiang University · Updated on 2026-01-20

450

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the use of high flow nasal cannula oxygenation (HFNC) to reduce the risk of low oxygen levels (hypoxia) during sedated gastrointestinal endoscopy in critically ill patients with American Anesthesiologist Rating (ASA) grades 3 to 4. This study compares HFNC with regular nasal cannula oxygen in patients undergoing these procedures to better understand how HFNC might help prevent breathing problems and related complications during sedation. Participants will be randomly assigned to one of two groups: one receiving oxygen through a high flow nasal cannula device called Airvo2, delivering oxygen at 60L/min with 100% concentration during the procedure; the other group will receive oxygen via a regular nasal catheter at 6L/min. Oxygen delivery starts before anesthesia induction and continues throughout the endoscopy, which is expected to last no more than 60 minutes. The study is conducted at multiple centers and uses a single-blind design where patients do not know which oxygen method they receive. During the hospital stay, which typically lasts about two hours, researchers will monitor participants for episodes of hypoxia, severe hypoxia, and subclinical respiratory depression. They will also track sedation-related and respiratory complications to evaluate safety and effectiveness. The main outcome is the rate of hypoxia during the procedure. This trial includes adults aged 18 to 80 years undergoing elective gastroenteroscopy with a body mass index between 18 and 28 kg/m2 and ASA grades 2 to 3.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years
  • Undergoing elective gastroenteroscopy or treatment
  • American Society of Anesthesiologists (ASA) grade 2 or 3
  • Body mass index (BMI) between 18 and 28 kg/m2
  • Expected gastroenteroscopy operation time of no more than 60 minutes
  • Able to understand the study and provide informed consent personally or through family
Not Eligible

You will not qualify if you...

  • Nasal congestion, nasal bleeding, recent nasal trauma or surgery, increased intracranial pressure, or skull fracture preventing high flow nasal oxygen
  • Acute respiratory infections or asthma attacks
  • Diagnosis of chronic obstructive pulmonary disease (COPD)
  • Known difficult airway
  • Acute upper gastrointestinal bleeding with shock
  • Gastrointestinal obstruction with gastric content retention
  • Allergy to sedatives such as propofol
  • Cognitive dysfunction or inability to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - About 2 hours on the day of the procedure

Participants receive oxygen through either a high-flow nasal catheter or a regular nasal catheter during sedated gastrointestinal endoscopy.

1 procedure visit (in-person)

Trial Site Locations

Total: 3 locations

1

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, China, 518000

Actively Recruiting

2

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, China, 518116

Actively Recruiting

3

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

Loading map...

Research Team

D

Diansan SU, Cheif of Anesthesiology Department, PhD

S

Shuying Fu

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Similar Trials

A Novel COMBinATorial Therapy With Albumin and Enoxaparin in...

Liver Cirrhosis

Actively Recruiting

9 locations

PROMISE Trial: A PROspective Randomised Double-blind Paralle...

Liver Cirrhosis

Actively Recruiting

23 locations

Development of a Breath Test Using Volatile Organic Markers ...

Liver Cirrhosis

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here