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

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ClinicalTrials.gov Identifier: NCT01458444
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : September 1, 2015
Sponsor:
Collaborators:
Centre Hospitalier René Dubos
Hopital Jean Minjoz
University Hospital, Bordeaux
University Hospital, Clermont-Ferrand
Hopital Louis Pradel
Information provided by (Responsible Party):
Centre Chirurgical Marie Lannelongue

Study Description
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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.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Device: Non invasive ventilation (VNI) Device: Non invasive ventilation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 830 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Respiratory Failure After Cardio Thoracic Surgery: Non Invasive Ventilation (VNI) by BIPAP Vision Versus OPTIFLOW System, Comparison.
Study Start Date : May 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: BIPAP
Non invasive ventilation (VNI) by BIPAP® vision
 Device: Non invasive ventilation (VNI)
BIPAP® vision
Experimental: OPTIFLOW
OPTIFLOW system
 Device: Non invasive ventilation
OPTIFLOW system


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Sensation of dyspnea [ Time Frame: one week ]
  2. Skin tolerance and comfort [ Time Frame: One week ]
  3. Evolution of hemodynamic and respiratory parameters [ Time Frame: one week ]
  4. number of bronchoscopy performed during the patient's stay in Intensive Care Unit [ Time Frame: one week ]
  5. number of postoperative pneumonia and antibiotic use [ Time Frame: one week ]
  6. length of stay in intensive care [ Time Frame: one week ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01458444


Locations
France
Centre Chirurgical MarieLannelongue
Le Plessis Robinson, Ile de France, France, 92350
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue
Centre Hospitalier René Dubos
Hopital Jean Minjoz
University Hospital, Bordeaux
University Hospital, Clermont-Ferrand
Hopital Louis Pradel
Investigators
Principal Investigator: François STEPHAN, MD CCML
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier: NCT01458444     History of Changes
Other Study ID Numbers: SC11-007
2011-A00125-36 ( Other Identifier: ANSM )
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015

Keywords provided by Centre Chirurgical Marie Lannelongue:
Respiratory Insufficiency
Cardiothoracic Surgery
Ventilation system

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
 Lung Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases