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High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol (HONCHO)

Primary Purpose

Hypoxia, Gastric Cancer, Esophagus Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High-flow nasal cannula oxygenation
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, Gastroscope, High-flow nasal cannula

Eligibility Criteria

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

Inclusion Criteria:

  • patients undergoing gastroscope
  • age over 18 years old
  • Signed informed consent form

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 hemodynamic 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 >III;
  • Mouth, nose, or throat infection;
  • Fever, defined as core body temperature > 37.5oC ;
  • Pregnancy, breastfeeding or positive pregnancy test
  • Emergency procedure

Sites / Locations

  • Shanghai Tongji Hospital
  • Renji hospital, School of Medicine, Shanghai Jiaotong University
  • Shanghai Pudong New Area People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

High-flow nasal cannula group

Arm Description

Oxygen(2L/min) supplied with nasal catheter

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of subclinical respiratory depression
(90% ≤ SpO2 < 95%)
Incidence of severe hypoxia
(SpO2 < 75% for any duration or 75% ≤ SpO2 < 90% for >/=60 s)
Other adverse events
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
October 26, 2017
Last Updated
September 2, 2018
Sponsor
RenJi Hospital
Collaborators
Shanghai Pudong New Area People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03332433
Brief Title
High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol
Acronym
HONCHO
Official Title
High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol: a Randomized Multicentre Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 10, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
March 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
Collaborators
Shanghai Pudong New Area People's Hospital, Shanghai Tongji 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
Yes

5. Study Description

Brief Summary
Hypoxia is the most common adverse events during sedated gastroscopy. In present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the hypoxia. At the same time the feasibility and safety will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Gastric Cancer, Esophagus Cancer, Adverse Event
Keywords
Hypoxia, Gastroscope, High-flow nasal cannula

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2034 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Oxygen(2L/min) supplied with 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
Primary Outcome Measure Information:
Title
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
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
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
Description
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
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients undergoing gastroscope age over 18 years old Signed informed consent form 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 hemodynamic 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 >III; Mouth, nose, or throat infection; Fever, defined as core body temperature > 37.5oC ; Pregnancy, breastfeeding or positive pregnancy test Emergency procedure
Facility Information:
Facility Name
Shanghai Tongji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
Renji hospital, School of Medicine, Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Shanghai Pudong New Area People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
31278907
Citation
Lin Y, Zhang X, Li L, Wei M, Zhao B, Wang X, Pan Z, Tian J, Yu W, Su D. High-flow nasal cannula oxygen therapy and hypoxia during gastroscopy with propofol sedation: a randomized multicenter clinical trial. Gastrointest Endosc. 2019 Oct;90(4):591-601. doi: 10.1016/j.gie.2019.06.033. Epub 2019 Jul 3.
Results Reference
derived

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High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol

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