Benefits of High Flow Nasal Cannula Oxygen for Preoxygenation During Intubation in Non Severely Hypoxemic Patients

Study Overview
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Brief Summary
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The aim of this study is to determine whether High Flow nasal cannula (HFNC) oxygen is more efficient than the standard High Flow face mask (HFFM) for preoxygenation before orotracheal intubation after crash induction in non severely hypoxemic patients

Detailed Description
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This study will be designed as followed : patients will be randomized in 2 groups : High Flow nasal cannula HFNC or standard High Flow face mask HFFM. Patients randomized in HFNC group will receive a four minutes preoxygenation period with Nasal High Flow Therapy (60 L/mn , fraction of inspired oxygen (FI02) = 100%) before orotracheal intubation under laryngoscopy after crash induction. After induction and during laryngoscopy, HFNC will be maintained in an attempt to achieve apneic oxygenation. Patients randomized in HFFM group will received a four minutes preoxygenation period with standard face mask (15 L/mn) before orotracheal intubation under laryngoscopy after crash induction. After induction, HFFM will be removed, enabling laryngoscopic vision

Official Title
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A Prospective , Multicenter , Randomized, Controlled, Parallel-group , Open-label Trial Evaluating Benefits of High Flow Nasal Cannula (HFNC) Oxygen for Preoxygenation During Intubation in Non Severely Hypoxemic Patients

Conditions
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Need for Intubation, No Severe Hypoxemia

Intervention / Treatment
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* Device: OPTIFLOW/ AIRVO
* 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 Requiring orotracheal intubation in intensive care unit No severely hypoxemic respiratory failure defined as Oxygen Pression (Pa02)/FI02 > 200 mmHg measured in the 4 hours before inclusion Exclusion Criteria: Not the first Intubation during this stay in intensive care unit Contraindication to oro-tracheal intubation Intubation without anaesthesic rapid sequence induction Intubation during cardiac arrest Real emergency (as asphyxia) with immediate intubation needed (without time enough for randomization) Nasopharyngeal obstacle with contraindication to use Optiflow device Patients with a documented Cormack IV exposition before inclusion Protected adult Pregnancy or breastfeeding Lack of consent Patient already enrolled in another study that could interfere with the primary objective of this 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: High Flow nasal cannula oxygen (HFNC)<br>Patients randomized in HFNC group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) Optiflow ®/Airvo® (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction. | Device: OPTIFLOW/ AIRVO<br>* Patients randomized in HFNC group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) Optiflow ®/AIRVO® (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction.<br>|
| Active Comparator: STANDARD high flow Face Mask (HFFM)<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. | 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lowest pulse oxymetry (SpO2) during intubation | This outcome will be assessed from the beginning of the endotracheal intubation procedure (immediately after induction) to the end of orotracheal intubation (airway catheterization) by monitoring the pulse oxymetry | From the beginning of the endotracheal intubation procedure (beginning of laryngoscopy, immediately after induction) to completed orotracheal intubation (airway catheterization). Usual duration is inferior to 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse oximetry |  | from the beginning of preoxygenation period to the end of intubation procedure. Usual duration is inferior to 15 minutes | 
| number of desaturation events (under 80%) |  | From the beginning of the endotracheal intubation procedure (beginning of laryngoscopy, immediately after induction) to completed orotracheal intubation (airway catheterization). Usual duration is inferior to 10 minutes) | 
| Reduction in morbi-mortality during the Intensive care Unit stay |  | from beginning of the preoxygenation period to discharged from intensive care unit (until day 28 for more) | 
| SOFA score |  | Each day during the 5 first days after randomisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non severely hypoxemic respiratory failure, preoxygenation, crash induction