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High-flow Nasal Oxygenation in Obese Patients During Apnea

Primary Purpose

Apneic Oxygenation, High-flow Nasal Cannulae, Bariatric Surgery

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HFNC
CON (control)
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apneic Oxygenation

Eligibility Criteria

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

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

Sites / Locations

  • Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HFNC (High Flow Nasal Cannulae)

CON (control)

Arm Description

High Flow Nasal Cannulae providing humidified, high-flow oxygen during induction of anesthesia

Standard flow oxygen during induction of anesthesia

Outcomes

Primary Outcome Measures

Measurement of safe apnea time
Safe apnea time, defined by time to desaturation (SpO2 > 95%) or apnea maximum up to 6 minutes

Secondary Outcome Measures

Highest EtCO2
Highest EtCO2 on commencing ventilation
Lowest SpO2
Lowest SpO2 during intubation procedure
Time to regain baseline SpO2
Time to regain baseline SpO2 after intubation

Full Information

First Posted
June 5, 2017
Last Updated
April 17, 2019
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03195504
Brief Title
High-flow Nasal Oxygenation in Obese Patients During Apnea
Official Title
Effectiveness of Apneic Oxygenation Using High-flow Nasal Cannula in Morbidly Obese Patients Undergoing General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 10, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
April 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apneic Oxygenation, High-flow Nasal Cannulae, Bariatric Surgery, Anesthesia Induction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Consented patients will be randomly assigned either to the interventional group (High Flow Nasal Cannula- HFNC) or to the control group (CON). The Group HFNC will be preoxygenated using HFNC and the Group CON will receive standard preoxygenation.
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HFNC (High Flow Nasal Cannulae)
Arm Type
Experimental
Arm Description
High Flow Nasal Cannulae providing humidified, high-flow oxygen during induction of anesthesia
Arm Title
CON (control)
Arm Type
Active Comparator
Arm Description
Standard flow oxygen during induction of anesthesia
Intervention Type
Device
Intervention Name(s)
HFNC
Intervention Description
High flow nasal oxygen (60 l) under GA
Intervention Type
Device
Intervention Name(s)
CON (control)
Intervention Description
Standard oxygen (10-15 l) under GA
Primary Outcome Measure Information:
Title
Measurement of safe apnea time
Description
Safe apnea time, defined by time to desaturation (SpO2 > 95%) or apnea maximum up to 6 minutes
Time Frame
Maximum up to 6 minutes
Secondary Outcome Measure Information:
Title
Highest EtCO2
Description
Highest EtCO2 on commencing ventilation
Time Frame
Every minute up to 5 minutes on commencing ventilation
Title
Lowest SpO2
Description
Lowest SpO2 during intubation procedure
Time Frame
Every minute up to 5 minutes after intubation
Title
Time to regain baseline SpO2
Description
Time to regain baseline SpO2 after intubation
Time Frame
Up to 5 minutes after intubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31584919
Citation
Wong DT, Dallaire A, Singh KP, Madhusudan P, Jackson T, Singh M, Wong J, Chung F. High-Flow Nasal Oxygen Improves Safe Apnea Time in Morbidly Obese Patients Undergoing General Anesthesia: A Randomized Controlled Trial. Anesth Analg. 2019 Oct;129(4):1130-1136. doi: 10.1213/ANE.0000000000003966.
Results Reference
derived

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High-flow Nasal Oxygenation in Obese Patients During Apnea

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