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

Primary Purpose

Gastric Cancer, Intestinal Cancer, Intestine Adenoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High-flow nasal cannula oxygenation
Regular nasal cannula oxygenation
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastric Cancer focused on measuring Gastroscopy, High-flow nasal oxygenation, Hypoxia, High-risk, Colonoscopy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Second Hospital Affiliated to Chongqing Medical University
  • Henan Provincial people's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-flow nasal cannula oxygenation group

Regular nasal cannula oxygenation group

Arm Description

Outcomes

Primary Outcome Measures

The incidence of hypoxia
Hypoxia refers to 75%≤SpO2<90%,<60S

Secondary Outcome Measures

The incidence of severe hypoxia
Severe hypoxia refers to SpO2<75% lasting for any time, or 75%≤SpO2<90%, ≥60s
The incidence of subclinical respiratory depression
Subclinical respiratory depression refers to 90%≤ SpO2<95%
Other adverse events evaluated by the tool of World SIVA
Complications related to high-flow nasal cannula

Full Information

First Posted
August 17, 2022
Last Updated
August 18, 2022
Sponsor
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05510388
Brief Title
HFNO Reduces Hypoxia During Sedated Gastroscopy or Colonoscopy in High Risk Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Intestinal Cancer, Intestine Adenoma, Gastritis
Keywords
Gastroscopy, High-flow nasal oxygenation, Hypoxia, High-risk, Colonoscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-flow nasal cannula oxygenation group
Arm Type
Experimental
Arm Title
Regular nasal cannula oxygenation group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
High-flow nasal cannula oxygenation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Regular nasal cannula oxygenation
Intervention Description
The patients receive an oxygen flow of 6L/min for preoxygenation with a disposal regular nasal cannula until the end of procedure.
Primary Outcome Measure Information:
Title
The incidence of hypoxia
Description
Hypoxia refers to 75%≤SpO2<90%,<60S
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary Outcome Measure Information:
Title
The incidence of severe hypoxia
Description
Severe hypoxia refers to SpO2<75% lasting for any time, or 75%≤SpO2<90%, ≥60s
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Title
The incidence of subclinical respiratory depression
Description
Subclinical respiratory depression refers to 90%≤ SpO2<95%
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Title
Other adverse events evaluated by the tool of World SIVA
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Title
Complications related to high-flow nasal cannula
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wanfeng Liu
Phone
+8613817793010
Email
liuwanfeng@renji.com
Facility Information:
Facility Name
The Second Hospital Affiliated to Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
404100
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
He Huang
Facility Name
Henan Provincial people's hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiaqiang Zhang

12. IPD Sharing Statement

Plan to Share IPD
No

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

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