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

Not Applicable

• Conditions: Gastric Cancer; Intestinal Cancer; Intestine Adenoma; Gastritis
• Interventions: Device: Regular nasal cannula oxygenation; Device: High-flow nasal cannula oxygenation

• Registration Number: NCT05510388
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-17
• Study First Submitted QC: 2022-08-18
• Last Update Submitted: 2022-08-18
• Study First Posted: 2022-08-22
• Last Update Posted: 2022-08-22
• Study Start: 2022-09-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regular nasal cannula oxygenation group	Regular nasal cannula oxygenation	-
High-flow nasal cannula oxygenation group	High-flow nasal cannula oxygenation	-

Primary Outcome Measures

Name	Time	Method
The incidence of hypoxia	Patients will be followed for the duration of hospital stay, an expected average of 2 hours	Hypoxia refers to 75%≤SpO2\<90%,\<60S

Secondary Outcome Measures

Name	Time	Method
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 severe hypoxia	Patients will be followed for the duration of hospital stay, an expected average of 2 hours	Severe hypoxia refers to SpO2\<75% lasting for any time, or 75%≤SpO2\<90%, ≥60s
The incidence of subclinical respiratory depression	Patients will be followed for the duration of hospital stay, an expected average of 2 hours	Subclinical respiratory depression refers to 90%≤ SpO2\<95%
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

Trial Locations

Locations (2)

The Second Hospital Affiliated to Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

Henan Provincial people's hospital; 🇨🇳 Zhengzhou, Henan, China