Respiratory Insufficiency
Conditions
Keywords
Respiratory Insufficiency, Cardiothoracic Surgery, Ventilation system
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.
Interventions
DEVICENon invasive ventilation (VNI)
BIPAP® vision
DEVICENon invasive ventilation
OPTIFLOW system
Sponsors
Hôpital NOVO
Hopital Jean Minjoz
University Hospital, Bordeaux
University Hospital, Clermont-Ferrand
Hopital Louis Pradel
Centre Chirurgical Marie Lannelongue
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure of the ventilation system | One week | Failure defined by reintubation rate, refusal to continue the technique, or switch to an another technique proposed breakdown |
Secondary
| Measure | Time frame |
|---|---|
| Skin tolerance and comfort | One week |
| Evolution of hemodynamic and respiratory parameters | one week |
| Sensation of dyspnea | one week |
| number of postoperative pneumonia and antibiotic use | one week |
| length of stay in intensive care | one week |
| number of bronchoscopy performed during the patient's stay in Intensive Care Unit | one week |
Countries
France
Outcome results
None listed