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

NCT07252102 · tracked via the Priya Life Science China tracker

Sponsor

Zhejiang University

Phase

Not applicable

Started

2025-11-20

Last updated

2026-01-20

Condition(s) studied

Liver CirrhosisPolyps of ColonGastrointestinal Dysfunction

Investigational drug(s) / intervention(s)

High-flow nasal catheter oxygenregular nasal catheter oxygen

High-flow nasal catheter oxygen: Before induction of anesthesia, connect the Airvo2 (HFNC high flow device) special nasal cannula to inhale oxygen, and preoxygenate with an oxygen flow rate of 6L /min. After induction of anesthesia, adjust the oxygen flow rate to 60L /min, oxygen concentration 100%, oxygen temperature 37℃ until the end of gastrointestinal endoscopy.

regular nasal catheter oxygen: Before anesthesia induction, a disposable nasal catheter oxygen inhalation device (covered by HFNC nasal catheter and blinded to the patient) was connected to an oxygen source for pre-oxygen inhalation, 6L/min. After induction of anesthesia, oxygen was continued for 6L/min until the end of gastroenteroscopy.

Study summary

High flow nasal cannula oxygenation (HFNC) offers high flow and concentration oxygen delivery, providing excellent non-respiratory oxygenation. As a relatively new oxygen delivery method, it has gained widespread use. We have demonstrated that high flow nasal cannula oxygenation reduce the incidence of hypoxia during sedated gastrointestinal endoscopy in patients with American Anesthesiologist Rating (ASA rating) grades 1 to 2 and obesity. We hypothesized that HFNC could mitigate the risk of hypoxia in critical patients during sedated gastrointestinal endoscopy. To confirm this, we selected critical patients with ASA grades 3 to 4 who were scheduled for gastrointestinal endoscopy. We observed and compared the incidence of hypoxia (75%≤SpO2 \< 90% and \< 60S), severe hypoxia (SpO2\<75% for any duration or 75%≤SpO2 \< 90%, ≥60s), subclinical respiratory depression (90%≤SpO2 \< 95%), respiratory-related adverse events, sedation-related adverse events, and complications associated with high flow nasal cannula oxygenation using HFNC or regular nasal cannula during the sedated gastrointestinal endoscopy.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

Incidence of hypoxia — Patients will be followed for the duration of hospital stay, an expected average about 2 hours
75%≤ SpO2 \< 90% and \< 60S

Trial sites (3)

Facility	City	Region	Status
Shenzhen Hospital of Southern Medical University	Shenzhen	Guangdong	Recruiting
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center	Shenzhen	Guangdong	Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	Recruiting

More Zhejiang University trials in China

A Study to Evaluate Safety and Feasibility of Robotic Liver Resection Recruiting

The Safety and Efficacy of Cetuximab Beta Plus Fruquintinib With or Without Immune Checkpoint Inhibitorrs in First-line Treatment of RAS/BRAF Wild Type Unresectable Metastatic Colorectal Cancer Recruiting

T Cell Receptor Gene-Engineered and Dominant Negative TGF-β Receptor T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor Active, not recruiting

A Multi-domain Lifestyle Intervention Among Aged Community-residents in Zhejiang, China Recruiting

Physician and Patient Preferences for Cell Therapies in Advanced Solid Tumors Recruiting

Other trials for the same condition

Comparison of Underdilated Versus Standard TIPS in Preventing Variceal Rebleeding in Patients With Cirrhosis Recruiting

Digital Early Warning System for Acute Lung Injury in Liver Surgery Recruiting

Establishment of a Model for Predicting the Prognosis of HBV-related Decompensated Liver Cirrhosis Based on RFH-NPT Active, not recruiting

Pantoprazole After Prophylactic Endoscopic Variceal Treatment Enrolling by invitation

Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Variceal Bleeding and Renal Dysfunction Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07252102 on ClinicalTrials.gov ↗ ← All trials in China