HFNO Reduces Hypoxia During Sedated Gastroscopy or Colonoscopy in High Risk Patients (HRISK)

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Gastritis; Gastric Cancer; Intestine Adenoma; Intestinal Cancer

Treatments: Device: Regular nasal cannula oxygenation; Device: High-flow nasal cannula oxygenation

Study type: Interventional

Funder types: Other

Identifiers

NCT05510388

KY2022-116-B

Details and patient eligibility

About

The objective of this study is to observe the preventive effects of high flow nasal oxygenation on the incidence of hypoxia during gastroscopy or colonoscopy sedated with propofol in high-risk patients.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ranging from 18 to 80, both sexes
2. Patients receiving selective gastroscopy or colonoscopy or gastroscopy and colonoscopy procedure
3. ASA Ⅲ~Ⅳ
4. 18 kg/m2<BMI<28kg/m2
5. The anticipated operation time of the procedure shall be less than 30min.
6. Patients should clearly understand and voluntarily participate in the study, with signed informed consent.

Exclusion criteria

1. Patients with nasal congestion, epistaxis, recent nasal trauma, recent nasal surgery, increased intracranial pressure and skull fracture, etc. who can not tolerate high-flow nasal cannula.
2. Patients diagnosed POCD
3. Patients clearly identified difficult airway
4. Patients with mechanical ventilation
5. Patients with acute respiratory infection and asthma
6. Patients with acute upper gastrointestinal hemorrhage accompanied by shock, severe anemia, gastrointestinal obstruction accompanied by retention of gastric contents
7. Patients with aortic stenosis and carotid stenosis
8. Patients allergic to sedatives such as propofol
9. Patients without civil capacity such as cognitive dysfunction

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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450 participants in 2 patient groups

High-flow nasal cannula oxygenation group

Experimental group

Treatment:

Device: High-flow nasal cannula oxygenation

Regular nasal cannula oxygenation group

Active Comparator group

Treatment:

Device: Regular nasal cannula oxygenation