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

Sponsor

RenJi Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05510388

Collaborator

(none)

450

Enrollment

Locations

Arms

9.9

Anticipated Duration (Months)

225

Patients Per Site

22.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer Intestinal Cancer Intestine Adenoma Gastritis	Device: High-flow nasal cannula oxygenation Device: Regular nasal cannula oxygenation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High-flow nasal cannula oxygenation group	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.
Active Comparator: Regular nasal cannula oxygenation group	Device: 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.

Arm

Intervention/Treatment

Experimental: High-flow nasal cannula oxygenation group

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.

Active Comparator: Regular nasal cannula oxygenation group

Device: 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.

Outcome Measures

Primary Outcome Measures

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

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]
Complications related to high-flow nasal cannula [Patients will be followed for the duration of hospital stay, an expected average of 2 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ranging from 18 to 80, both sexes
Patients receiving selective gastroscopy or colonoscopy or gastroscopy and colonoscopy procedure
ASA Ⅲ~Ⅳ
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Hospital Affiliated to Chongqing Medical University	Chongqing	Chongqing	China	404100
2	Henan Provincial people's hospital	Zhengzhou	Henan	China	450000