High-flow Nasal Cannula Oxygenation Reduces the Incidence of Hypoxia During Gastroscopy or Colonoscopy Sedated With Propofol in High-risk Patients: a Multi Central Randomized Controlled Study

RenJi Hospital2 sites in 1 country450 target enrollmentSeptember 1, 2022

ConditionsGastric Cancer Intestinal Cancer Intestine Adenoma Gastritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gastric Cancer
Sponsor: RenJi Hospital
Enrollment: 450
Locations: 2
Primary Endpoint: The incidence of hypoxia
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2022

End Date

June 30, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

RenJi Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ranging from 18 to 80, both sexes
•Patients receiving selective gastroscopy or colonoscopy or gastroscopy and colonoscopy procedure
•18 kg/m2\<BMI\<28kg/m2
•The anticipated operation time of the procedure shall be less than 30min.
•Patients should clearly understand and voluntarily participate in the study, with signed informed consent.

Exclusion Criteria

•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.
•Patients diagnosed POCD
•Patients clearly identified difficult airway
•Patients with mechanical ventilation
•Patients with acute respiratory infection and asthma
•Patients with acute upper gastrointestinal hemorrhage accompanied by shock, severe anemia, gastrointestinal obstruction accompanied by retention of gastric contents
•Patients with aortic stenosis and carotid stenosis
•Patients allergic to sedatives such as propofol
•Patients without civil capacity such as cognitive dysfunction

Outcomes

Primary Outcomes

The incidence of hypoxia

Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Hypoxia refers to 75%≤SpO2\<90%,\<60S

Secondary Outcomes

Complications related to high-flow nasal cannula(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
The incidence of subclinical respiratory depression(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
Other adverse events evaluated by the tool of World SIVA(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
The incidence of severe hypoxia(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)