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

Centre Chirurgical Marie Lannelongue

Status: Completed

Conditions: Respiratory Insufficiency

Treatments: Device: Non invasive ventilation; Device: Non invasive ventilation (VNI)

Study type: Interventional

Funder types: Other

Identifiers

NCT01458444

SC11-007

2011-A00125-36 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 830 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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830 participants in 2 patient groups

BIPAP

Active Comparator group

Description:

Non invasive ventilation (VNI) by BIPAP® vision

Treatment:

Device: Non invasive ventilation (VNI)

OPTIFLOW

Experimental group

Description:

OPTIFLOW system

Treatment:

Device: Non invasive ventilation