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

Gastric Cancer Clinical Trial

— HRISK  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05510388
• Other study ID #: KY2022-116-B
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2022
• Source: RenJi Hospital
• Contact: Wanfeng Liu
• Phone: +8613817793010
• Email: liuwanfeng[@]renji.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 ?~?

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

Related Conditions & MeSH terms

• Adenoma
• Gastric Cancer
• Gastritis
• Hypoxia
• Intestinal Cancer
• Intestinal Neoplasms

Intervention

Device:
• High-flow nasal cannula oxygenation
The patients receive oxygen flow of 6L/min for preoxygenation with an high-flow canular oxygenation device before losing of conscious. Then, the oxygen flow is adjusted to 60L/min with the oxygen concentration of 100% and the temperature of 37? until the end of procedure.
• Regular nasal cannula oxygenation
The patients receive an oxygen flow of 6L/min for preoxygenation with a disposal regular nasal cannula until the end of procedure.

Locations

Country	Name	City	State
China	The Second Hospital Affiliated to Chongqing Medical University	Chongqing	Chongqing
China	Henan Provincial people's hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of hypoxia	Hypoxia refers to 75%=SpO2<90%,<60S	Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary	The incidence of severe hypoxia	Severe hypoxia refers to SpO2<75% lasting for any time, or 75%=SpO2<90%, =60s	Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary	The incidence of subclinical respiratory depression	Subclinical respiratory depression refers to 90%= SpO2<95%	Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary	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
Secondary	Complications related to high-flow nasal cannula		Patients will be followed for the duration of hospital stay, an expected average of 2 hours