Clinical trial NCT03106441: Preoxygenation Optimisation in Obese Patients
Official title: PREOPTI-POOP: Preoxygenation Optimisation in Obese Patients: High-flow Nasal Cannula Oxygen Versus Non-invasive Ventilation : A Single-centre Randomized Controlled Study. "
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Obesity Design as BMI > 35kg/m2
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Expired fraction of oxygen at the end of intubation
timeFrame: 2 minutes
Secondary outcomes:
measure: Improvement of quality of preoxygenation
timeFrame: 4 minutes
measure: Reduction in side effects incidence related to intubation
timeFrame: 1 hour
measure: morbi-mortality during surgery
timeFrame: 6 hour
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital, Hôtel Dieu, Medical intensive care unit
Study officials:
affiliation: Nantes University Hospital
name: Karim Asehnoune, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vourc'h M, Baud G, Feuillet F, Blanchard C, Mirallie E, Guitton C, Jaber S, Asehnoune K. High-flow Nasal Cannulae Versus Non-invasive Ventilation for Preoxygenation of Obese Patients: The PREOPTIPOP Randomized Trial. EClinicalMedicine. 2019 Jun 5;13:112-119. doi: 10.1016/j.eclinm.2019.05.014. eCollection 2019 Aug.