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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Centre Chirurgical Marie Lannelongue

Current Primary Outcome: Failure of the ventilation system [ Time Frame: One week ]

Failure defined by reintubation rate, refusal to continue the technique, or switch to an another technique proposed breakdown


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Centre Chirurgical Marie Lannelongue

Dates:
Date Received: October 21, 2011
Date Started: May 2011
Date Completion:
Last Updated: August 30, 2015
Last Verified: August 2015