High-flow Nasal Oxygenation in Obese Patients During Apnea

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Completed
• CT.gov ID: NCT03195504
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.7
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Apneic Oxygenation; High-flow Nasal Cannulae; Bariatric Surgery; Anesthesia Induction	Device: HFNC; Device: CON (control)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Apneic Oxygenation Using High-flow Nasal Cannula in Morbidly Obese Patients Undergoing General Anesthesia
• Actual Study Start Date: Aug 10, 2017
• Actual Primary Completion Date: Apr 1, 2018
• Actual Study Completion Date: Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HFNC (High Flow Nasal Cannulae) High Flow Nasal Cannulae providing humidified, high-flow oxygen during induction of anesthesia	Device: HFNC; High flow nasal oxygen (60 l) under GA
Active Comparator: CON (control) Standard flow oxygen during induction of anesthesia	Device: CON (control); Standard oxygen (10-15 l) under GA

Outcome Measures

Primary Outcome Measures

1. 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

1. Highest EtCO2 [Every minute up to 5 minutes on commencing ventilation]

   Highest EtCO2 on commencing ventilation

2. Lowest SpO2 [Every minute up to 5 minutes after intubation]

   Lowest SpO2 during intubation procedure

3. Time to regain baseline SpO2 [Up to 5 minutes after intubation]

   Time to regain baseline SpO2 after intubation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8

Sponsors and Collaborators

• University Health Network, Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Wong, Professor Anesthesia (MD), University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT03195504
• Other Study ID Numbers: 16-6264.0
• First Posted: Jun 22, 2017
• Last Update Posted: Apr 19, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Apnea

Study Results

No Results Posted as of Apr 19, 2019