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High-flow Nasal Oxygenation in Obese Patients During Apnea

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03195504
Enrollment
40
Registered
2017-06-22
Start date
2017-08-10
Completion date
2018-04-01
Last updated
2019-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEHFNC

High flow nasal oxygen (60 l) under GA

DEVICECON (control)

Standard oxygen (10-15 l) under GA

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measurement of safe apnea timeMaximum up to 6 minutesSafe apnea time, defined by time to desaturation (SpO2 \> 95%) or apnea maximum up to 6 minutes

Secondary

MeasureTime frameDescription
Highest EtCO2Every minute up to 5 minutes on commencing ventilationHighest EtCO2 on commencing ventilation
Lowest SpO2Every minute up to 5 minutes after intubationLowest SpO2 during intubation procedure
Time to regain baseline SpO2Up to 5 minutes after intubationTime to regain baseline SpO2 after intubation

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026