Preoxygenation Optimisation in Obese Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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PREOPTI-POOP: Preoxygenation Optimisation in Obese Patients: High-flow Nasal Cannula Oxygen Versus Non-invasive Ventilation : A Single-centre Randomized Controlled Study. 

Conditions
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Severe Obesity Design as BMI > 35kg/m2

Intervention / Treatment
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* Device: High flow oxygen therapy by nasal cannula. Optiflow®
* Device: Facial mask oxygenation in BIPAP ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High flow oxygen therapy by nasal cannula<br>Experimental Device : High flow oxygen therapy by nasal cannula. | Device: High flow oxygen therapy by nasal cannula. Optiflow®<br>* Patients randomized in interventional group will received a four minutes preoxygenation period with High Flow nasal cannula (60 l/mn FiO2 = 1) before orotracheal intubation. The device will be maintained in place throughout the intubation procedure in order to achieve apnoeic oxygenation.<br>|
| Active Comparator: Facial mask oxygenation in BIPAP ventilation<br>Active Comparator: Facial mask oxygenation in BIPAP ventilation | Device: Facial mask oxygenation in BIPAP ventilation<br>* Patients randomized in BIPAP group will receive a four minutes preoxygenation with EPAP 5, IPAP 15 FiO2 = 1 for a pressure support of 10 cm H2O. The facial mask with be removed after before crash induction enabling laryngoscopic vision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expired fraction of oxygen at the end of intubation | To determine whether High-Flow nasal cannula used during the preoxygenation in obese patient is more efficient than BIPAP preoxygenation. | 2 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of quality of preoxygenation | duration of proceedings | 4 minutes | 
| Reduction in side effects incidence related to intubation | Notification of adverse events during the intubation period | 1 hour | 
| morbi-mortality during surgery | Per and postoperative complication rate | 6 hour |