Preoxygenation Optimisation in Obese Patients (PREOPTI-POOP)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Severe Obesity Design as BMI > 35kg/m2

Treatments: Device: Facial mask oxygenation in BIPAP ventilation; Device: High flow oxygen therapy by nasal cannula. Optiflow®

Study type: Interventional

Funder types: Other

Identifiers

NCT03106441

RC17_0046

Details and patient eligibility

About

Oro-tracheal intubation in operating room in obese patients with BMI > 35kg/m2 remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® is more efficient than the BIPAP preoxygenation before orotracheal intubation after crash induction in obese patients

Full description

This study will be designed as followed : Patients will be randomized in 2 groups :

Preoxygenation during 4 minutes with High Flow Nasal Cannula (60l/min FiO2 (fraction of inspired oxygen) = 1) before orotracheal intubation after crash induction. The device will be maintained in place throughout the intubation procedure in order to achieve apnoeic oxygenation. Or Preoxygenation during 4 minutes with Bi-level Positive Airway Pressure (BIPAP) with Expiratory Positive Airway Pressure (EPAP) + 5 cm H2O and Inspiratory Airway Positive Airway Pressure (IPAP) + 15, meaning a 10cm H2O pressure support. The facial mask with be removed after before crash induction enabling laryngoscopic vision.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Obese patient with BMI > 35kg/m2
• Age between 18 and 80 years
• Requiring a crash induction sequence for oro-tracheal intubation.

Exclusion criteria

• Pulse oxymetry < 90% in ambient air
• Haemodynamic instability
• Burned patient
• Indication of intubation vigil in spontaneous ventilation
• Patients with a documented Cormack IV exposition before inclusion
• Protected adult
• Pregnancy
• Lack of consent
• Patient already enrolled in an other randomized study looking forward improving preoxygenation quality.
• Lack of French social protection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

High flow oxygen therapy by nasal cannula

Experimental group

Description:

Experimental Device : High flow oxygen therapy by nasal cannula.

Treatment:

Device: High flow oxygen therapy by nasal cannula. Optiflow®

Facial mask oxygenation in BIPAP ventilation

Active Comparator group

Description:

Active Comparator: Facial mask oxygenation in BIPAP ventilation

Treatment:

Device: Facial mask oxygenation in BIPAP ventilation