Preoxygenation for Difficult Airway Management

Study Overview
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Brief Summary
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Tracheal intubation in operating room for patients at risk of difficult intubation remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® administered before and during intubation is more efficient than the standard care for pre-oxygenation and oxygenation during anticipated difficult intubation

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 = 1) before and during intubation. The device will be maintained in place throughout the intubation procedure (including fiber-optic or laryngoscopic) in order to achieve oxygenation. Or Standard Preoxygenation during 4 minutes with FIBROXY® (Fiber-optic intubation) or standard facial mask (Laryngoscopic intubation), at FiO2=100%. FIBROXY mask will be maintained in place during the fiberoptic procedure. Standard facial mask, will be removed after the crash induction.

Official Title
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PREOPTI-DAM: High-flow Nasal Cannula Oxygen Versus Standard Oxygenation During Intubation for Patient at Risk of Difficult Intubation: A Randomized Controlled Clinical Trial

Conditions
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Intubation;Difficult

Intervention / Treatment
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* Device: Preoxygenation with high flow therapy by nasal cannula
* Device: Preoxygenation by standard Facial mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of aged and over And anticipated difficult intubation And requiring a rapid sequence induction for laryngoscopic intubation Or requiring a fiberoptic intubation Exclusion Criteria: BMI > 35 Pulse oxymetry < 90% in ambient air Haemodynamic instability Pregnancy Protected adult Lack of consent Patient already enrolled in another randomized study looking forward improving preoxygenation quality.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoxygenation with high flow therapy by nasal cannula<br>High flow oxygen therapy by nasal cannula. | Device: Preoxygenation with high flow therapy by nasal cannula<br>* Preoxygenation during 4 minutes with High Flow Nasal Cannula (60l/min FiO2 = 1) before fiber-optic or laryngoscopic intubation. The device will be maintained in place throughout the intubation procedure in order to achieve oxygenation.<br>|
| Active Comparator: Preoxygenation by standard Facial mask<br>Patients randomized in STANDARD FACIAL MASK group will receive a four minutes preoxygenation period with a standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction or Fiber-optic intubation under spontaneous ventilation. | Device: Preoxygenation by standard Facial mask<br>* For Fiber-optic intubation: patients will receive a 4 minutes FIBROXY facial mask preoxygenation with FiO2=100%. The FIBROXY facial mask will be maintained in place during the intubation procedure. For Laryngoscopic intubation: patients will receive a 4 minutes standard facial mask preoxygenation with FiO2=100%. The standard facial mask will be removed after crash induction to proceed to intubation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of desaturation below 95% or manual facial mask reventilation during ETI procedure. | To determine whether High-Flow nasal cannula used for preoxygenation and oxygenation during intubation, is more efficient than standard care during difficult intubation. This outcome will be assessed from the beginning of the preoxygenation period to the end of orotracheal intubation by monitoring the pulse oxymetry. | 4 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of quality of preoxygenation | duration of proceedings | 4 minutes | 
| Reduction in side effects incidence related to intubation |  | 6 hours | 
| Morbi-mortality during surgery. | Per and postoperative complication rate | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoxygenation, High flow nasal cannula