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HFNO Combined With NPA Reduces Hypoxia During Sedated Gastrointestinal Endoscopy In Obese Patients

Primary Purpose

Gastric Cancer, Gastric Ulcer, Intestinal Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High-flow nasal oxygenation combined with nasopharyngeal airway
Regular nasal cannula combined with nasopharyngeal airway
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 High-flow nasal oxygenation, Gastrointestinal endoscopy, Hypoxia

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients receiving selective combined upper intestinal and lower intestinal endoscopy procedure under deep sedation.
  2. Age ranging from 19 to 80, both male and female
  3. Obese patients，BMI ≥ 28kg/m^2
  4. ASA I~III
  5. Patients should clearly understand and voluntarily participate in the study, with signed informed consent.

Exclusion Criteria:

  1. Patients with acute respiratory infection in the last 2 weeks
  2. Patients with nasal congestion, epistaxis, recent nasal trauma, recent nasal surgery
  3. hypoxia, defined as oxygen saturation measured by pulse oximetry (SpO2) ≤ 95% before preoxygenation.
  4. Common advanced gastrointestinal endoscopy procedures meeting eligibility criteria included cholangiopancreatography, endoscopic ultrasound procedures, endoscopic mucosal resection and endoscopic retrograde cholangiopancreatography (ERCP) procedures.
  5. coagulation disorders or platelets < 100*10^9/L
  6. Have serious heart diseases such as severe arrhythmia, heart failure, Adams Stokes Disease, unstable angina pectoris, myocardial infarction in the last 6 months, history of tachycardia / bradycardia requiring medical treatment, third degree atrioventricular block or QTC interval ≥ 450ms (corrected according to fridericia's formula), or exercise tolerance < 4mets
  7. Allergy to eggs, soy products, opioids and other drugs, propofol, etc.
  8. Participated in other clinical trials as a subject within 3 months
  9. Patients with brain injury, possible convulsion, myoclonus, intracranial hypertension, cerebral aneurysm, cerebrovascular accident history, schizophrenia, intellectual disability, mania, psychosis, long-term use of psychotropic drugs, drug addiction, cognitive dysfunction history, etc.
  10. Emergency procedure
  11. Pregnant or breast-feeding women
  12. Patients having procedures with planned tracheal intubation or laryngeal mask
  13. Investigator considers the patients are inappropriate to participate in this trial

Sites / Locations

  • Dushu Lake Hospital Affiliated to Soochow University
  • Second Hospital Affiliated to Soochow University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-flow nasal oxygenation combined with nasopharyngeal airway

Regular nasal cannula combined with nasopharyngeal airway

Arm Description

High-flow nasal oxygenation combined with nasopharyngeal airway was used in obese patients who are scheduled to undergo gastrointestinal endoscopy procedures sedated with propofol.

Regular nasal cannula combined with nasopharyngeal airway was used in obese patients who are scheduled to undergo gastrointestinal endoscopy procedures sedated with propofol.

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%
The incidence of other adverse events
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force

Full Information

First Posted
August 31, 2022
Last Updated
August 31, 2022
Sponsor
RenJi Hospital
Collaborators
Second Affiliated Hospital of Soochow University, Dushu Lake Hospital Affiliated to Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT05526339
Brief Title
HFNO Combined With NPA Reduces Hypoxia During Sedated Gastrointestinal Endoscopy In Obese Patients
Official Title
High-Flow Nasal Oxygenation Combined With Nasopharyngeal Airway Reduces The Incidence Of Hypoxia During Gastrointestinal Endoscopy Sedated With Propofol In Obese Patients: A Prospective, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
Collaborators
Second Affiliated Hospital of Soochow University, Dushu Lake Hospital Affiliated to Soochow University

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
Obesity is associated with adverse airway events including desaturation during deep sedation. Previous studies have suggested that high-flow nasal oxygenation may be superior to regular (low-flow) nasal cannula for prevention of hypoxia during Sedated Gastrointestinal Endoscopy in non-obesity patients. The prerequisite of high-flow nasal oxygenation is keeping airway patency. Our pervious study demonstrated that nasopharyngeal airway has the similar efficacy of jaw-lift. In present study we aimed to determine whether high-flow nasal oxygenation combined with nasopharyngeal airway could reduce the incidence of hypoxia during Sedated Gastrointestinal Endoscopy in obese patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastric Ulcer, Intestinal Cancer, Intestinal Polyps
Keywords
High-flow nasal oxygenation, Gastrointestinal endoscopy, Hypoxia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-flow nasal oxygenation combined with nasopharyngeal airway
Arm Type
Experimental
Arm Description
High-flow nasal oxygenation combined with nasopharyngeal airway was used in obese patients who are scheduled to undergo gastrointestinal endoscopy procedures sedated with propofol.
Arm Title
Regular nasal cannula combined with nasopharyngeal airway
Arm Type
Active Comparator
Arm Description
Regular nasal cannula combined with nasopharyngeal airway was used in obese patients who are scheduled to undergo gastrointestinal endoscopy procedures sedated with propofol.
Intervention Type
Device
Intervention Name(s)
High-flow nasal oxygenation combined with nasopharyngeal airway
Intervention Description
The patients receive an oxygen flow of 30 L/min for preoxygenation with a high-flow oxygenation device before losing of conscious. At the time of the abolition of the eyelash reflex, the gas flow was increased to 60 L/min with an inspired oxygen fraction 100% and the nasopharyngeal airway was placed.
Intervention Type
Device
Intervention Name(s)
Regular nasal cannula combined with nasopharyngeal airway
Intervention Description
The patients receive an oxygen flow of 6 L/min for preoxygenation with a regular nasal cannula until the end of procedure. At the time of abolition of the eyelash reflex, the nasopharyngeal airway was placed.
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
The incidence of other adverse events
Description
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
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
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients receiving selective combined upper intestinal and lower intestinal endoscopy procedure under deep sedation. Age ranging from 19 to 80, both male and female Obese patients，BMI ≥ 28kg/m^2 ASA I~III Patients should clearly understand and voluntarily participate in the study, with signed informed consent. Exclusion Criteria: Patients with acute respiratory infection in the last 2 weeks Patients with nasal congestion, epistaxis, recent nasal trauma, recent nasal surgery hypoxia, defined as oxygen saturation measured by pulse oximetry (SpO2) ≤ 95% before preoxygenation. Common advanced gastrointestinal endoscopy procedures meeting eligibility criteria included cholangiopancreatography, endoscopic ultrasound procedures, endoscopic mucosal resection and endoscopic retrograde cholangiopancreatography (ERCP) procedures. coagulation disorders or platelets < 100*10^9/L Have serious heart diseases such as severe arrhythmia, heart failure, Adams Stokes Disease, unstable angina pectoris, myocardial infarction in the last 6 months, history of tachycardia / bradycardia requiring medical treatment, third degree atrioventricular block or QTC interval ≥ 450ms (corrected according to fridericia's formula), or exercise tolerance < 4mets Allergy to eggs, soy products, opioids and other drugs, propofol, etc. Participated in other clinical trials as a subject within 3 months Patients with brain injury, possible convulsion, myoclonus, intracranial hypertension, cerebral aneurysm, cerebrovascular accident history, schizophrenia, intellectual disability, mania, psychosis, long-term use of psychotropic drugs, drug addiction, cognitive dysfunction history, etc. Emergency procedure Pregnant or breast-feeding women Patients having procedures with planned tracheal intubation or laryngeal mask Investigator considers the patients are inappropriate to participate in this trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diansan Su
Phone
+8618616514088
Email
diansansu@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lingke Chen
Phone
+8618601795041
Email
www.clk@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diansan Su
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dushu Lake Hospital Affiliated to Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Facility Name
Second Hospital Affiliated to Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Zhu

12. IPD Sharing Statement

Plan to Share IPD
No

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HFNO Combined With NPA Reduces Hypoxia During Sedated Gastrointestinal Endoscopy In Obese Patients

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