Preoxygenation Using NIV in Hypoxemic Patients

Study Overview
=================
Brief Summary
-----------------
Critically ill patients are predisposed to oxyhaemoglobin desaturation during intubation. For the intubation of hypoxemic patients, preoxygenation using non invasive ventilation (NIV) is more effective at reducing arterial oxyhaemoglobin desaturation than standard method. Objectives: To find out whether NIV, as a preoxygenation method, is more effective at reducing the degree of organ dysfunction/failure than standard preoxygenation during the week following endotracheal intubation.

Detailed Description
-----------------
During the inclusion period (at least 10 min and maximum 30 min), the patients ware a high FiO2 mask, driven by 10-15L/min oxygen and are randomly assigned to control or NIV group. Preoxygenation is then performed for a 3 minute period prior to a standardized rapid sequence intubation. For the control group, preoxygenation use a non-re-breather bag-valve mask driven by 15L/min oxygen. Patients allow to breath spontaneously with occasional assists (usual preoxygenation method). For the NIV group, pressure support mode is delivered by an ICU ventilator through a face mask adjusted to obtain an expired tidal volume of 7 to 10 mL/kg. The fraction of inspired oxygen (FiO2) was 100% and we used a PEEP level of 5 cmH2O.

Official Title
-----------------
Preoxygenation Using Noninvasive Ventilation Prior Intubation in Hypoxemic Patients

Conditions
-----------------
Critical Illness, Hypoxemia

Intervention / Treatment
-----------------
* Procedure: Non Invasive Ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults patients with acute respiratory failure requiring intubation Exclusion Criteria: Encephalopathy or coma, cardiac resuscitation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Non Invasive Ventilation | Procedure: Non Invasive Ventilation<br>* Non Invasive Ventilation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum Sequential organ failure assessment (SOFA) score observed during the first week following endotracheal intubation. |  | the first week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean drop in SpO2 during endotracheal intubation. |  | during the intubation | 
| Number of organ failures (SOFA score >2) |  | during the 7 days after intubation | 
| ICU length of stay |  | during the stay in reanimation | 
| Mortality |  | in reanimation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preoxygenation, Non Invasive Ventilation, Continuous Positive Airway Pressure,, Intubation,, Organ failure