High-flow Nasal Oxygenation in Obese Patients During Apnea

NCT ID: NCT03195504

Last Updated: 2019-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-10

Study Completion Date

2018-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Apneic Oxygenation High-flow Nasal Cannulae Bariatric Surgery Anesthesia Induction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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HFNC (High Flow Nasal Cannulae)

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

Group Type EXPERIMENTAL

HFNC

Intervention Type DEVICE

High flow nasal oxygen (60 l) under GA

CON (control)

Standard flow oxygen during induction of anesthesia

Group Type ACTIVE_COMPARATOR

CON (control)

Intervention Type DEVICE

Standard oxygen (10-15 l) under GA

Interventions

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HFNC

High flow nasal oxygen (60 l) under GA

Intervention Type DEVICE

CON (control)

Standard oxygen (10-15 l) under GA

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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David Wong

Professor Anesthesia (MD)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 31584919 (View on PubMed)

Other Identifiers

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16-6264.0

Identifier Type: -

Identifier Source: org_study_id

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