Preoxygenation, Anesthesia, Obesity
Conditions
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.
Interventions
Preoxygenation trough High Flow Nasal Cannula (HFNC) at 100% FiO2, 50 liters/min and closed mouth. After Rapid Sequence Induction (RSI), maintenance of apnea with HFNC at 100% FiO2, 70 liters/min and jaw thrust. At time of peripheral oxygen saturations (SpO2) decreases by 2% or after 10 minutes of apnea, the participant is intubated.
DEVICEStandard anesthesia FaceMask (FM)
Preoxygenation trough standard anesthesia FaceMask (FM) at 100% FiO2, 12 liters/min, CPAP 7 cmH2O. After Rapid Sequence Induction (RSI), maintenance of apnea without mask. At time of peripheral oxygen saturations (SpO2) decreases by 2% or after 10 minutes of apnea, the participant is intubated.
Sponsors
Erasme University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Belgium
Outcome results
None listed