Preoxygenation Optimisation in Obese Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-21

Study Completion Date

2018-04-12

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

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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.

Conditions

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Severe Obesity Design as BMI > 35kg/m2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High flow oxygen therapy by nasal cannula

Experimental Device : High flow oxygen therapy by nasal cannula.

Group Type EXPERIMENTAL

High flow oxygen therapy by nasal cannula. Optiflow®

Intervention Type 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 ventilation

Active Comparator: Facial mask oxygenation in BIPAP ventilation

Group Type ACTIVE_COMPARATOR

Facial mask oxygenation in BIPAP ventilation

Intervention Type DEVICE

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

Interventions

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High 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.

Intervention Type DEVICE

Facial 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

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No