High-flow Nasal Oxygenation in Obese Patients During Apnea

NCT03195504 | Completed

• 1 other identifier: 16-6264.0
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Apneic Oxygenation; High-flow Nasal Cannulae; Bariatric Surgery; Anesthesia Induction

Outcome Measures

Primary Outcomes (1)

• Measurement of safe apnea time

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

  Maximum up to 6 minutes

Secondary Outcomes (3)

• Highest EtCO2

  Every minute up to 5 minutes on commencing ventilation

• Lowest SpO2

  Every minute up to 5 minutes after intubation

• Time to regain baseline SpO2

  Up to 5 minutes after intubation

Study Arms (2)

HFNC (High Flow Nasal Cannulae)

EXPERIMENTAL

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

Device: HFNC

CON (control)

ACTIVE COMPARATOR

Standard flow oxygen during induction of anesthesia

Device: CON (control)

Interventions

HFNC DEVICE

High flow nasal oxygen (60 l) under GA

HFNC (High Flow Nasal Cannulae)

CON (control) DEVICE

Standard oxygen (10-15 l) under GA

CON (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (1)

• 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.

  PMID: 31584919 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Anesthesia (MD)

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 22, 2017
• Study Start: August 10, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 19, 2019

Record last verified: 2019-04

Locations

CA (1)