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

January 9, 2024 updated by: diansan su, RenJi Hospital

High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity: a Randomized Multicenter Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai, China
      • Shanghai, Shanghai, China, China, 200065
        • Recruiting
        • Shanghai Tongji Hospital
        • Contact:
      • Shanghai, Shanghai, China, China, 200120
      • Shanghai, Shanghai, China, China, 200127
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiaotong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-flow nasal cannula group
Oxygen(up to 60L/min) supplied with high-flow nasal cannula
Device: High-flow nasal cannula oxygenation
Oxygen is supplied with a high-flow nasal cannula oxygenation device#the flow is up to 60L/min
Active Comparator: Control group
Oxygen(up to 6L/min) supplied with a regular nasal catheter
Device: Regular nasal cannula
Oxygen is supplied with a regular nasal cannula #the flow is up to 6L/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of hypoxia
Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours]
(75% ≤ SpO2 < 90% for <60 s)
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 subclinical respiratory depression
Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
(90% ≤ SpO2 < 95%)
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
The incidence of severe hypoxia
Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
(SpO2 < 75% for any duration or 75% < SpO2 < 90% for >/=60 s)
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
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
Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai Oriental Hospital, Tongji University School of Medicine

Investigators

  • Principal Investigator: Diansan Su, Dr., Renji Hospital, Shanghai Jiaotong University, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2021

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

August 2, 2020

First Submitted That Met QC Criteria

August 2, 2020

First Posted (Actual)

August 5, 2020

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFNOIO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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