Clinical trial NCT03615417: High-Flow Nasal Cannula (HFNC) Preoxygenation in Obese Patients Undergoing General Anesthesia
Official title: Effectiveness of High-Flow Nasal Cannula (HFNC) Preoxygenation in Obese Patients Undergoing General Anesthesia: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoxygenation
Anesthesia
Obesity
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the effectiveness of the High Flow Nasal Cannula (HFNC) for the preoxygenation of obese patients undergoing a general anesthesia. The HFNC interface is compared to a standard anesthesia FaceMask (FM) preoxygenation with Continuous Positive Airway Pressure (CPAP), the current gold standard procedure for obese induction.

The interest of HFNC preoxygenation is to increase the "safe apnea time" before critical arterial desaturation, useful in the management of difficult airways, especially in subjects with reduced respiratory reserves such as the obese.


Eligibility criteria: Inclusion Criteria:

* Surgery with the need for general anesthesia with muscle relaxation
* ASA (American Society of Anesthesiologists) physical status score II-III
* BMI \> 35

Exclusion Criteria:

* Severe respiratory disease (acute respiratory failure, Chronic obstructive pulmonary disease COPD, parenchymal pneumopathies,...)
* Severe nasal pathology (malformation, stenosis)
* Criteria or previous difficult intubation
* BMI \> 50
* Chest circumference \> 150cm
* Implanted electronic device (pacemaker, neurostimulator, ...)
* Pregnancy

Primary outcomes:
measure: Functional Residual Capacity (FRC) variation
timeFrame: 20 minutes
Secondary outcomes:
measure: Time of safe apnea
timeFrame: 20 minutes
measure: Lowest SpO2
timeFrame: 20 minutes
measure: Preoxygenation Comfort
timeFrame: 6 hours
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme University Hospital
Study officials:
affiliation: Erasme University Hospital
name: Francesco Ricottilli, MD
role: PRINCIPAL_INVESTIGATOR
References:
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