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

This study has been completed.
Sponsor:
Collaborators:
Centre Hospitalier René Dubos
CHUJean Minjoz, 25030 Besançon,France
CHU de Bordeaux,33604 PESSAC,France
University Hospital, Clermont-Ferrand
CHU de lyon, Hopital Louis Pradel,69500 Bron,France
Information provided by (Responsible Party):
Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier:
NCT01458444
First received: October 21, 2011
Last updated: January 23, 2014
Last verified: January 2014

October 21, 2011
January 23, 2014
May 2011
January 2014   (final data collection date for primary outcome measure)
Failure of the ventilation system [ Time Frame: One week ] [ Designated as safety issue: No ]
Failure defined by reintubation rate, refusal to continue the technique, or switch to an another technique proposed breakdown
Same as current
Complete list of historical versions of study NCT01458444 on ClinicalTrials.gov Archive Site
  • Sensation of dyspnea [ Time Frame: one week ] [ Designated as safety issue: No ]
  • Skin tolerance and comfort [ Time Frame: One week ] [ Designated as safety issue: Yes ]
  • Evolution of hemodynamic and respiratory parameters [ Time Frame: one week ] [ Designated as safety issue: No ]
  • number of bronchoscopy performed during the patient's stay in Intensive Care Unit [ Time Frame: one week ] [ Designated as safety issue: No ]
  • number of postoperative pneumonia and antibiotic use [ Time Frame: one week ] [ Designated as safety issue: Yes ]
  • length of stay in intensive care [ Time Frame: one week ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
BIPAP Vision Versus OPTIFLOW System Comparison in Acute Respiratory Failure After Cardio Thoracic Surgery
Acute Respiratory Failure After Cardio Thoracic Surgery: Non Invasive Ventilation (VNI) by BIPAP Vision Versus OPTIFLOW System, Comparison.

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Respiratory Insufficiency
  • Device: Non invasive ventilation (VNI)
    BIPAP® vision
  • Device: Non invasive ventilation
    OPTIFLOW system
  • Active Comparator: BIPAP
    Non invasive ventilation (VNI) by BIPAP® vision
    Intervention: Device: Non invasive ventilation (VNI)
  • Experimental: OPTIFLOW
    OPTIFLOW system
    Intervention: Device: Non invasive ventilation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
830
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01458444
SC11-007, 2011-A00125-36
Yes
Centre Chirurgical Marie Lannelongue
Centre Chirurgical Marie Lannelongue
  • Centre Hospitalier René Dubos
  • CHUJean Minjoz, 25030 Besançon,France
  • CHU de Bordeaux,33604 PESSAC,France
  • University Hospital, Clermont-Ferrand
  • CHU de lyon, Hopital Louis Pradel,69500 Bron,France
Principal Investigator: François STEPHAN, MD CCML
Centre Chirurgical Marie Lannelongue
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP