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

Zhejiang University logo

Zhejiang University

Status

Enrolling

Conditions

Liver Cirrhosis
Gastrointestinal Dysfunction
Polyps of Colon

Treatments

Device: regular nasal catheter oxygen
Device: High-flow nasal catheter oxygen

Study type

Interventional

Funder types

Other

Identifiers

NCT07252102
ZJU2025C036

Details and patient eligibility

About

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.

Enrollment

450 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

450 participants in 2 patient groups

High-flow nasal catheter oxygen
Experimental group
Treatment:
Device: High-flow nasal catheter oxygen
Regular nasal catheter oxygen
Active Comparator group
Treatment:
Device: regular nasal catheter oxygen

Trial contacts and locations

3

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Central trial contact

Diansan SU, Cheif of Anesthesiology Department, PhD; Shuying Fu

Data sourced from clinicaltrials.gov

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