High-flow Nasal Oxygenation in Obese Patients During Apnea

Not Applicable

Completed

• Conditions: High-flow Nasal Cannulae; Bariatric Surgery; Anesthesia Induction; Apneic Oxygenation
• Interventions: Device: HFNC; Device: CON (control)

• Registration Number: NCT03195504
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-05
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-22
• Study Start: 2017-08-10
• Primary Completion: 2018-04-01
• Study Completion: 2018-04-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HFNC (High Flow Nasal Cannulae)	HFNC	High Flow Nasal Cannulae providing humidified, high-flow oxygen during induction of anesthesia
CON (control)	CON (control)	Standard flow oxygen during induction of anesthesia

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada