Using high-flow nasal cannulas to prevent oxygen drops during sedated GI endoscopy in critically ill patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Critically ill adults (ASA grade 3–4) scheduled for elective gastrointestinal endoscopy will be assigned to receive either high-flow nasal catheter oxygen or standard nasal catheter oxygen during sedation. The study compares the incidence of hypoxia, severe hypoxia, and subclinical respiratory depression using predefined SpO2 thresholds and durations. Investigators will also record respiratory- and sedation-related adverse events and procedure-related complications. The trial is conducted at multiple tertiary hospitals in China and focuses on procedures expected to last 60 minutes or less.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shenzhen Hospital of Southern Medical University
  Shenzhen, Guangdong, China Recruiting
• Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
  Shenzhen, Guangdong, China Recruiting
• The First Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.