Preoxygenation Optimisation in Obese Patients

Not Applicable

Completed

• Conditions: Severe Obesity Design as BMI > 35kg/m2
• Interventions: Device: High flow oxygen therapy by nasal cannula. Optiflow®; Device: Facial mask oxygenation in BIPAP ventilation

• Registration Number: NCT03106441
• Lead Sponsor: Nantes University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-10
• Study Start: 2017-06-21
• Primary Completion: 2018-04-12
• Study Completion: 2018-04-12
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-03
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Obese patient with BMI > 35kg/m2
• Age between 18 and 80 years
• Requiring a crash induction sequence for oro-tracheal intubation.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High flow oxygen therapy by nasal cannula	High flow oxygen therapy by nasal cannula. Optiflow®	Experimental Device : High flow oxygen therapy by nasal cannula.
Facial mask oxygenation in BIPAP ventilation	Facial mask oxygenation in BIPAP ventilation	Active Comparator: Facial mask oxygenation in BIPAP ventilation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Nantes University Hospital, Hôtel Dieu, Medical intensive care unit; 🇫🇷 Nantes, France