Severe Obesity Design as BMI > 35kg/m2
Conditions
Brief summary
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
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.
Interventions
DEVICEHigh flow oxygen therapy by nasal cannula. Optiflow®
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.
DEVICEFacial mask oxygenation in BIPAP ventilation
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
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expired fraction of oxygen at the end of intubation | 2 minutes | To determine whether High-Flow nasal cannula used during the preoxygenation in obese patient is more efficient than BIPAP preoxygenation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of quality of preoxygenation | 4 minutes | duration of proceedings |
| Reduction in side effects incidence related to intubation | 1 hour | Notification of adverse events during the intubation period |
| morbi-mortality during surgery | 6 hour | Per and postoperative complication rate |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORKarim Asehnoune, PHD
Nantes University Hospital
Outcome results
None listed