Preoxygenation Optimisation in Obese Patients

Nantes University Hospital100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Severe Obesity Design as BMI > 35kg/m2

Interventions

High flow oxygen therapy by nasal cannula. Optiflow®DEVICE

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.

Facial mask oxygenation in BIPAP ventilationDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Nantes University Hospital, Hôtel Dieu, Medical intensive care unit

Nantes, France

Outcomes

Primary Outcomes

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.

Time frame: 2 minutes

Secondary Outcomes

Improvement of quality of preoxygenation

duration of proceedings

Time frame: 4 minutes

Reduction in side effects incidence related to intubation

Notification of adverse events during the intubation period

Time frame: 1 hour

morbi-mortality during surgery

Per and postoperative complication rate

Time frame: 6 hour

Data from ClinicalTrials.gov

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