High-flow Nasal Oxygenation in Obese Patients During Apnea

NCT03195504 — Not applicable, Completed, 40 participants, University Health Network, Toronto

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

Registry	NCT03195504
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	40 (Actual)
Sponsor	University Health Network, Toronto (Other)
Conditions	Apneic Oxygenation, High-flow Nasal Cannulae, Bariatric Surgery, Anesthesia Induction
Interventions	HFNC, CON (control) (Device)
Dates	start 2017-08-10, primary completion 2018-04-01, completion 2018-04-01, first posted 2017-06-22, last updated 2019-04-19
Locations	1 site in Canada

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
HFNC (High Flow Nasal Cannulae)	Experimental	Device: HFNC	High Flow Nasal Cannulae providing humidified, high-flow oxygen during induction of anesthesia
CON (control)	Active comparator	Device: CON (control)	Standard flow oxygen during induction of anesthesia

HFNC (Device): High flow nasal oxygen (60 l) under GA
CON (control) (Device): Standard oxygen (10-15 l) under GA

+Outcome measures

Primary outcomes

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

Secondary outcomes

Highest EtCO2 [Every minute up to 5 minutes on commencing ventilation]: Highest EtCO2 on commencing ventilation
Lowest SpO2 [Every minute up to 5 minutes after intubation]: Lowest SpO2 during intubation procedure
Time to regain baseline SpO2 [Up to 5 minutes after intubation]: Time to regain baseline SpO2 after intubation

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Toronto Western Hospital	Toronto, Ontario	Canada

+Publications

Results publication: 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