Actively Recruiting
High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients: A Multicenter Randomized Trial
Led by Zhejiang University · Updated on 2026-05-04
600
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether the High-Flow Nasal Cannula (HFNC) can reduce the risk of hypoxia during sedated gastrointestinal endoscopy in patients at high risk for obstructive sleep apnea (OSA). These patients are identified using the STOP-BANG questionnaire, with a score of 5 or higher indicating increased susceptibility to hypoxia during sedation. Although initial studies suggest HFNC might help, more evidence is needed for patients with high-risk OSA. Participants are randomly assigned to one of two groups: one group uses the High-Flow Nasal Cannula for oxygen delivery, while the other uses a regular nasal cannula. The study focuses on sedated gastrointestinal procedures such as gastroscopy, colonoscopy, or both combined, with an expected procedure time of up to 45 minutes. This multicenter trial is designed to compare these two oxygenation methods during the procedure. During the hospital stay, lasting about 2 hours on average, researchers will monitor participants for the occurrence of hypoxia, sub-clinical respiratory depression, and severe hypoxia. The study tracks these outcomes closely to understand the safety and effectiveness of HFNC in this setting. Participants will be carefully observed throughout the procedure and recovery to provide detailed information on respiratory status under sedation.
CONDITIONS
Brief Title
High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- STOP-Bang score 5 or higher
- Scheduled for sedated gastrointestinal endoscopy (gastroscopy, colonoscopy, or combined)
- Estimated procedure duration 45 minutes or less
- Signed informed consent form
You will not qualify if you...
- Coagulation disorders or bleeding tendency
- Active upper respiratory infection or fever above 37.5�b0C
- Chronic obstructive pulmonary disease or other lung diseases requiring oxygen therapy
- Preoperative oxygen saturation (SpO2) 92% or lower on room air
- Severe organ dysfunction including cardiac, renal, hepatic, or brain conditions
- ASA physical status 4 or higher
- Confirmed pregnancy or current breastfeeding
- Known allergy to sedatives or medical adhesives
- Multiple traumatic injuries
- Current participation in another clinical trial
- Other conditions deemed unsuitable by the investigator
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.
1 visit (in-person)
Duration - Approximately 2 hours during hospital stay
Participants receive oxygenation through either a high-flow nasal cannula or a regular nasal cannula during sedated gastrointestinal endoscopy.
1 procedure visit (in-person)
Trial Site Locations
Total: 3 locations
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
2
The First Hospital Of Jiaxing
Jiaxing, Zhejiang, China, 314000
Actively Recruiting
3
Quzhou People's Hospital
Quzhou, Zhejiang, China, 324000
Actively Recruiting
Research Team
D
Diansan Su, Chief Physician
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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