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High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity

Primary Purpose

Hypoxia, Gastric Cancer, Esophagus Cancer

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

About this trial

This is an interventional prevention trial for Hypoxia focused on measuring Hypoxia, Gastrointestinal endoscopes, High-flow nasal cannula Oxygenation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients undergoing gastrointestinal endoscopes
  • age≥18 years old and ≤70 years old
  • patients or family members signed informed consent form
  • ASA classification I-II
  • BMI≥ 28kg/m²

Exclusion Criteria:

  • Coagulation disorders or a tendency of nose bleeding;
  • An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months;
  • Severe aortic stenosis or mitral stenosis;
  • Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months;
  • Acute myocardial infarction in the last 6 months;
  • Acute arrhythmia (including any tachycardia - or bradycardia) with the fluid of hemodynamics instability;
  • Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy);
  • Increased intracranial pressure;
  • ASA classification Ⅲ-Ⅳ ;
  • Mouth, nose, or throat infection;
  • Liver and kidney disease
  • Fever, defined as core body temperature > 37.5℃;
  • Pregnancy, breastfeeding or positive pregnancy test;
  • Emergency procedure;
  • Patients or family members refused to participate
  • Mental disorders and people without civil capacity

Sites / Locations

  • Shanghai Tongji HospitalRecruiting
  • Shanghai Oriental HospitalRecruiting
  • Renji hospital, School of Medicine, Shanghai Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

High-flow nasal cannula group

Arm Description

Oxygen(up to 6L/min) supplied with a regular nasal catheter

Oxygen(up to 60L/min) supplied with high-flow nasal cannula

Outcomes

Primary Outcome Measures

The incidence of hypoxia
(75% ≤ SpO2 < 90% for <60 s)

Secondary Outcome Measures

The incidence of subclinical respiratory depression
(90% ≤ SpO2 < 95%)
The incidence of severe hypoxia
(SpO2 < 75% for any duration or 75% < SpO2 < 90% for >/=60 s)
Other adverse events include other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events.

Full Information

First Posted
August 2, 2020
Last Updated
September 14, 2021
Sponsor
RenJi Hospital
Collaborators
Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai Oriental Hospital, Tongji University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04500392
Brief Title
High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity
Official Title
High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity: a Randomized Multicenter Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
Collaborators
Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai Oriental Hospital, Tongji University School of Medicine

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
Hypoxia is the most common adverse event during gastrointestinal endoscopes sedated with propofol and sufentanil, especially in obese people. In the present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the incidence of hypoxia among obesity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Gastric Cancer, Esophagus Cancer, Polyp of Colon, Colon Cancer
Keywords
Hypoxia, Gastrointestinal endoscopes, High-flow nasal cannula Oxygenation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Oxygen(up to 6L/min) supplied with a regular nasal catheter
Arm Title
High-flow nasal cannula group
Arm Type
Experimental
Arm Description
Oxygen(up to 60L/min) supplied with high-flow nasal cannula
Intervention Type
Device
Intervention Name(s)
High-flow nasal cannula oxygenation
Intervention Description
Oxygen is supplied with a high-flow nasal cannula oxygenation device#the flow is up to 60L/min
Intervention Type
Device
Intervention Name(s)
Regular nasal cannula
Intervention Description
Oxygen is supplied with a regular nasal cannula #the flow is up to 6L/min
Primary Outcome Measure Information:
Title
The incidence of hypoxia
Description
(75% ≤ SpO2 < 90% for <60 s)
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 subclinical respiratory depression
Description
(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 severe hypoxia
Description
(SpO2 < 75% for any duration or 75% < SpO2 < 90% for >/=60 s)
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Title
Other adverse events include other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events.
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
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients undergoing gastrointestinal endoscopes age≥18 years old and ≤70 years old patients or family members signed informed consent form ASA classification I-II BMI≥ 28kg/m² Exclusion Criteria: Coagulation disorders or a tendency of nose bleeding; An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months; Severe aortic stenosis or mitral stenosis; Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months; Acute myocardial infarction in the last 6 months; Acute arrhythmia (including any tachycardia - or bradycardia) with the fluid of hemodynamics instability; Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy); Increased intracranial pressure; ASA classification Ⅲ-Ⅳ ; Mouth, nose, or throat infection; Liver and kidney disease Fever, defined as core body temperature > 37.5℃; Pregnancy, breastfeeding or positive pregnancy test; Emergency procedure; Patients or family members refused to participate Mental disorders and people without civil capacity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diansan Su, Dr.
Phone
+862168383702
Email
diansansu@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diansan Su, Dr.
Organizational Affiliation
Renji Hospital, Shanghai Jiaotong University, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Tongji Hospital
City
Shanghai
State/Province
Shanghai, China
ZIP/Postal Code
200065
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoqing Zhang, M.S.
Email
xq_820175@163.com
Facility Name
Shanghai Oriental Hospital
City
Shanghai
State/Province
Shanghai, China
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangrui Wang, Dr.
Email
wangxr2010@yahoo.com
Facility Name
Renji hospital, School of Medicine, Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai, China
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Yuanyuan, B.S.
Phone
+862168383702
Email
2630643807@qq.com

12. IPD Sharing Statement

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High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity

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