BIPAP Vision Versus OPTIFLOW System Comparison in Acute Respiratory Failure After Cardio Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
The OPTIFLOW ™ use is becoming more common in acute respiratory failure cases, but its place in relation to VNI (Bi-PAP mode) is not yet defined. OPTIFLOW ™ vs the VNI comparison of the use, in the immediate postoperative period, should lead to define the role of each technique and lead to a optimal rationalization of patients management with acute respiratory failure after surgery.

Detailed Description
-----------------
Main objective: to determine, if the initiation of OPTIFLOW™ system immediate after cardio/ thoracic surgery with acute respiratory failure or immediate after post extubation in patients at risk, is not less than the start a VNI per BIPAP Vision ®system. In terms of reintubation rates, refusal to continue the technique, or switch to another technique proposed. Secondary objectives: To assess changes in the sensation of dyspnea To analyze the skin tolerance and the comfort in this population To analyze the evolution of hemodynamic and respiratory parameters To compare the number of bronchoscopy performed during the patient's stay in intensive care unit Assess the number of postoperative pneumonia and antibiotic consumption To determine whether the initiation of any treatment changes in the immediate postoperative length of stay in intensive care and comprehensive.

Official Title
-----------------
Acute Respiratory Failure After Cardio Thoracic Surgery: Non Invasive Ventilation (VNI) by BIPAP Vision Versus OPTIFLOW System, Comparison.

Conditions
-----------------
Respiratory Insufficiency

Intervention / Treatment
-----------------
* Device: Non invasive ventilation (VNI)
* Device: Non invasive ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients after cardiac/thoracic surgery with acute respiratory failure defined by the presence of the following criteria: report PaO2/FiO2 <300 Respiratory rate> 25 for at least 2 hours Getting involved accessory respiratory muscles paradoxical breathing Or In immediate after extubation, the patient will be eligible if present in the withdrawal test: SaO2 <90% in 12 L of O2 during a trial of spontaneous ventilation tube on PaO2 <10 kPa at a FiO2 ≥ 50% during a VS trial + pressure support The presence of a risk factor: Obesity (BMI> 30), FEVG <40%, Failed extubation prior, stridor Exclusion Criteria: Previous history of SAS Patient tracheotomy Comas non hypercapnic bradypnea Cardiac arrest Gastric Surgery recent Restlessness, lack of cooperation Nausea, vomiting Hemodynamic instability

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BIPAP<br>Non invasive ventilation (VNI) by BIPAP® vision | Device: Non invasive ventilation (VNI)<br>* BIPAP® vision<br>|
| Experimental: OPTIFLOW<br>OPTIFLOW system | Device: Non invasive ventilation<br>* OPTIFLOW system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure of the ventilation system | Failure defined by reintubation rate, refusal to continue the technique, or switch to an another technique proposed breakdown | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensation of dyspnea |  | one week | 
| Skin tolerance and comfort |  | One week | 
| Evolution of hemodynamic and respiratory parameters |  | one week | 
| number of bronchoscopy performed during the patient's stay in Intensive Care Unit |  | one week | 
| number of postoperative pneumonia and antibiotic use |  | one week | 
| length of stay in intensive care |  | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiothoracic Surgery, Ventilation system, Respiratory Insufficiency