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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastritis; Gastric Cancer; Intestinal Cancer; Intestine Adenoma
• Intervention / Treatment: Device: High-flow nasal cannula oxygenation; Device: Regular nasal cannula oxygenation

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wanfeng Liu; Phone Number: +8613817793010; Email: liuwanfeng@renji.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 404100
      • The Second Hospital Affiliated to Chongqing Medical University
      • Contact: He Huang
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Henan provincial people's hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Hypoxia; Colonoscopy; High-risk; High-flow nasal oxygenation; Gastroscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Signs and Symptoms, Respiratory; Gastritis; Adenoma; Hypoxia; Intestinal Neoplasms
• Other Study ID Numbers: KY2022-116-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No