Clinical trial NCT01458444: BIPAP Vision Versus OPTIFLOW System Comparison in Acute Respiratory Failure After Cardio Thoracic Surgery
Official title: Acute Respiratory Failure After Cardio Thoracic Surgery: Non Invasive Ventilation (VNI) by BIPAP Vision Versus OPTIFLOW System, Comparison.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Keywords: Respiratory Insufficiency
Cardiothoracic Surgery
Ventilation system
Lead sponsor: Centre Chirurgical Marie Lannelongue
Sponsor class: OTHER
Collaborators: name: Hôpital NOVO
name: Hopital Jean Minjoz
name: University Hospital, Bordeaux
name: University Hospital, Clermont-Ferrand
name: Hopital Louis Pradel
First posted: 2011-10-24
Enrollment: 830
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Failure of the ventilation system
timeFrame: One week
Secondary outcomes:
measure: Sensation of dyspnea
timeFrame: one week
measure: Skin tolerance and comfort
timeFrame: One week
measure: Evolution of hemodynamic and respiratory parameters
timeFrame: one week
measure: number of bronchoscopy performed during the patient's stay in Intensive Care Unit
timeFrame: one week
measure: number of postoperative pneumonia and antibiotic use
timeFrame: one week
measure: length of stay in intensive care
timeFrame: one week
Other outcomes:
Locations:
city: Le Plessis Robinson
country: France
facility: Centre Chirurgical MarieLannelongue
state: Ile de France
Study officials:
affiliation: CCML
name: François STEPHAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stephan F, Barrucand B, Petit P, Rezaiguia-Delclaux S, Medard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Berard L; BiPOP Study Group. High-Flow Nasal Oxygen vs Noninvasive Positive Airway Pressure in Hypoxemic Patients After Cardiothoracic Surgery: A Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2331-9. doi: 10.1001/jama.2015.5213.