High-flow Nasal Oxygenation in Obese Patients During Apnea

Bariatric Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03195504
• Other study ID #: 16-6264.0
• Status: Completed
• Phase: N/A
• Start date: August 10, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: April 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Highest EtCO2	Highest EtCO2 on commencing ventilation	Every minute up to 5 minutes on commencing ventilation
Secondary	Lowest SpO2	Lowest SpO2 during intubation procedure	Every minute up to 5 minutes after intubation
Secondary	Time to regain baseline SpO2	Time to regain baseline SpO2 after intubation	Up to 5 minutes after intubation