Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
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