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

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

This trial will test whether high-flow nasal cannulas during sedated gastrointestinal endoscopy can prevent low oxygen levels in critically ill (ASA 3–4) adults.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Zhejiang University (Academic / other)
• Locations: 3 sites (Shenzhen, Guangdong and 2 other locations)
• Trial ID: NCT07252102 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–80 having elective gastroenteroscopy with ASA grade 3–4, BMI 18–28 kg/m2, procedure time expected ≤60 minutes, and able to give informed consent are ideal candidates.

Not a fit: Patients who cannot use HFNC (nasal obstruction, recent nasal surgery/trauma, active nasal bleeding), those with COPD, acute respiratory infection or asthma attack, difficult airway, acute GI bleeding with shock, gastric outlet obstruction with retained contents, allergy to sedatives like propofol, or severe cognitive impairment are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, HFNC could reduce episodes of low oxygen and related complications during sedated GI procedures in high-risk patients.

How similar studies have performed: Previous studies have shown HFNC reduces hypoxia during sedated endoscopy in ASA 1–2 and obese patients, but its benefit in ASA 3–4 critical patients remains to be confirmed.

Eligibility criteria

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 this trial is running

Shenzhen, Guangdong and 2 other locations

• 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

Conditions Liver Cirrhosis; Polyps of Colon; Gastrointestinal Dysfunction; critical patients; HFNC; High flow nasal cannulas oxyge; hypoxia