High-Flow Nasal Cannula (HFNC) Preoxygenation in Obese Patients Undergoing General Anesthesia

Not Applicable

Completed

• Conditions: Anesthesia; Preoxygenation; Obesity
• Interventions: Device: High Flow Nasal Cannula (HFNC); Device: Standard anesthesia FaceMask (FM)

• Registration Number: NCT03615417
• Lead Sponsor: Erasme University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-19
• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-03
• Primary Completion: 2018-09-07
• Study Completion: 2018-09-07
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HFNC - High Flow Nasal Cannula	High Flow Nasal Cannula (HFNC)	Participants are preoxygenated by High Flow Nasal Cannula (HFNC) OptiFlow.
FM - FaceMask	Standard anesthesia FaceMask (FM)	Participants are preoxygenated by standard anesthesia FaceMask.

Primary Outcome Measures

Name	Time	Method
Functional Residual Capacity (FRC) variation	20 minutes	The difference of FRC, estimated by lung Electrical Impedance Tomography (EIT), during general anesthesia induction (from a base period to the mechanical ventilation).

Secondary Outcome Measures

Name	Time	Method
Time of safe apnea	20 minutes	The time (seconds) of apnea following preoxygenation and muscle relaxation before to peripheral oxygen saturations (SpO2) decreases by 2%, or the apnea time reaches 600 seconds.
Lowest SpO2	20 minutes	The lowest SpO2 (%) during general anesthesia induction (from a base period to the mechanical ventilation).
Preoxygenation Comfort	6 hours	The subjective comfort of the patient during the preoxygenation, expressed with a 0-5 scale at Post Anesthesia Care Unit (PACU) discharge.

Trial Locations

Locations (1)

Erasme University Hospital; 🇧🇪 Brussels, Belgium