Benefits of Optiflow® Device for Preoxygenation Before Intubation in Acute Hypoxemic Respiratory Failure : The PREOXYFLOW Study

Study Overview
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Brief Summary
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Oro-tracheal intubation in intensive unit care(ICU) in acute hypoxemic respiratory failure after crash induction remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy (HFT) Optiflow ® is more efficient than the face mask for preoxygenation before orotracheal intubation after crash induction in acute hypoxemic respiratory failure

Detailed Description
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This study will be designed as followed : Patients will be randomized in 2 groups :PREOXYFLOW or STANDARD FACE MASK. Patients randomized in PREOXYFLOW group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction. Patients randomized in STANDARD FACE MASK group will received a four minutes preoxygenation period with standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction

Official Title
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A Prospective, Multicenter, Randomized, Controlled, Parallel-group, Open Label Trial Evaluating Benefits of Nasal High Flow Therapy (HFT) in Preoxygenation Before Tracheal Intubation in Acute Hypoxemic Respiratory Failure

Conditions
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Acute Hypoxemic Respiratory Failure

Intervention / Treatment
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* Device: PREOXYFLOW
* Procedure: STANDARD FACE MASK


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults older than 18 years regardless of the gender Acute hypoxemic respiratory failure defined as : Respiratory rate > 30/mn AND Hypoxemia with SpO2 <90% with oxygen supply > FiO2 0,5 AND PaO2/FiO2 <300 mmHg Exclusion Criteria: Contraindication to oro-tracheal intubation Intubation without anesthetic delivery Intubation during cardiac arrest Asphyxia with immediate intubation needed Nasopharyngeal obstacle with contraindication to use Optiflow device Patients with a documented Cormack IV exposition before inclusion Protected adult Pregnancy Lack of consent Patient already enrolled in an other randomized study.

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: PREOXYFLOW<br>Patients randomized in PREOXYFLOW group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) Optiflow ® (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction | Device: PREOXYFLOW<br>* Patients randomized in PREOXYFLOW group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) Optiflow ® (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction<br>|
| Active Comparator: STANDARD FACE MASK<br>Patients randomized in STANDARD FACE MASK group will received a four minutes preoxygenation period with a standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction. No specific trademark is requested by the protocol. | Procedure: STANDARD FACE MASK<br>* Patients randomized in STANDARD FACE MASK group will received a four minutes preoxygenation period with a standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction. Each hospital involved in this study will use the standard face mask as per its usual practice (no specific trademark requested by this protocol)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine whether Optiflow® used during the preoxygenation period before orotracheal intubation after crash induction is more efficient than standard face mask. | 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 |  | 4 minutes | 
| Reduction in side effects incidence related to intubation |  | 1 hour | 
| Reduction in Organ failure in the 5th day |  | at day 5 | 
| Reduction in morbi-mortality during the Intensive Care Unit stay. |  | until day 28 OR, if patient still in the intensive care unit (ICU) at Day 28, until discharge of ICU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute hypoxemic respiratory failure, Preoxygenation, Crash induction