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

Sponsor
RenJi Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04500392
Collaborator
Shanghai Tongji Hospital, Tongji University School of Medicine (Other), Shanghai Oriental Hospital, Tongji University School of Medicine (Other)
1,000
3
2
18.9
333.3
17.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: High-flow nasal cannula oxygenation
  • Device: Regular nasal cannula
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity: a Randomized Multicenter Clinical Trial
Actual Study Start Date :
May 6, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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

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

Outcome Measures

Primary Outcome Measures

  1. The incidence of hypoxia [Patients will be followed for the duration of hospital stay, an expected average of 2 hours]]

    (75% ≤ SpO2 < 90% for <60 s)

Secondary Outcome Measures

  1. The incidence of subclinical respiratory depression [Patients will be followed for the duration of hospital stay, an expected average of 2 hours]

    (90% ≤ SpO2 < 95%)

  2. The incidence of severe hypoxia [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)

  3. 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. [Patients will be followed for the duration of hospital stay, an expected average of 2 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Tongji Hospital Shanghai Shanghai, China China 200065
2 Shanghai Oriental Hospital Shanghai Shanghai, China China 200120
3 Renji hospital, School of Medicine, Shanghai Jiaotong University Shanghai Shanghai, China China 200127

Sponsors and Collaborators

  • RenJi Hospital
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
diansan su, Vice Chair of the Department of Anesthesiology, RenJi Hospital
ClinicalTrials.gov Identifier:
NCT04500392
Other Study ID Numbers:
  • HFNOIO
First Posted:
Aug 5, 2020
Last Update Posted:
Sep 16, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by diansan su, Vice Chair of the Department of Anesthesiology, RenJi Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2021