High-flow Nasal Oxygenation in Obese Patients During Apnea

April 17, 2019 updated by: David Wong, University Health Network, Toronto

Effectiveness of Apneic Oxygenation Using High-flow Nasal Cannula in Morbidly Obese Patients Undergoing General Anesthesia

Before going off to sleep patients are given oxygen to saturate blood with oxygen to extend time before a decrease in the level of oxygen in the blood occurs. During this period, obese patients have a faster decrease in the level of oxygen in their blood. This study uses a device called "high-flow nasal cannula" (HFNC), which delivers humidified high-flow oxygen through 2 small plastic tubes placed just inside nostrils. In the intensive care unit settings this device has been used extensively and has become a standard practice. Purpose of this study is to determine whether these high-flow nasal cannula increase the time safely when going to sleep during elective surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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 Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age more than18 years old
  • ASA status I-III
  • Elective surgery performed under general anesthesia requiring endotracheal intubation
  • BMI more than 40 kg/m2

Exclusion Criteria:

  • Chronic respiratory disease
  • SpO2 <98% after supplementing oxygen
  • Previous or anticipated difficult intubation
  • Uncontrolled hypertension
  • Ischemic heart disease
  • Congestive heart failure
  • Increased intracranial pressure
  • Uncontrolled GERD
  • Known allergy or contraindication to anesthesia drugs
  • Nasal blockade contraindicating the use of HFNC

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HFNC (High Flow Nasal Cannulae)
High Flow Nasal Cannulae providing humidified, high-flow oxygen during induction of anesthesia
Device: HFNC
High flow nasal oxygen (60 l) under GA
Active Comparator: CON (control)
Standard flow oxygen during induction of anesthesia
Device: CON (control)
Standard oxygen (10-15 l) under GA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of safe apnea time
Time Frame: Maximum up to 6 minutes
Safe apnea time, defined by time to desaturation (SpO2 > 95%) or apnea maximum up to 6 minutes
Maximum up to 6 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Highest EtCO2
Time Frame: Every minute up to 5 minutes on commencing ventilation
Highest EtCO2 on commencing ventilation
Every minute up to 5 minutes on commencing ventilation
Lowest SpO2
Time Frame: Every minute up to 5 minutes after intubation
Lowest SpO2 during intubation procedure
Every minute up to 5 minutes after intubation
Time to regain baseline SpO2
Time Frame: Up to 5 minutes after intubation
Time to regain baseline SpO2 after intubation
Up to 5 minutes after intubation

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 10, 2017

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

June 5, 2017

First Submitted That Met QC Criteria

June 19, 2017

First Posted (Actual)

June 22, 2017

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-6264.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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