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

This study is currently recruiting participants.
Verified May 2013 by Centre Chirurgical Marie Lannelongue
Sponsor:
Collaborators:
Centre hospitalier Rene Dubos, 95303 Pontoise, France
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: May 20, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Respiratory Insufficiency
 Device: Non invasive ventilation (VNI)
Device: Non invasive ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Chirurgical Marie Lannelongue:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 840
Study Start Date: May 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458444

Contacts
Contact: François STEPHAN, MD, intensive care physician +33 (0) 1 40 94 85 80 f.stephan@ccml.fr
Contact: Mansouria MERAD BOUDIA, PharmD, PhD, Project Manager +33 (0) 1 40 94 25 96 m.merad@ccml.fr

Locations
France
Centre Chirurgical MarieLannelongue Recruiting
Le Plessis Robinson, Ile de France, France, 92350
Contact: François STEPHAN, MD, intensive care physician     +33 (0) 1 40 94 85 80     f.stephan@ccml.fr    
Contact: Mansouria MERAD BOUDIA, PhamD, PhD, Project Manager     +33 (0) 1 40 94 86 55     m.merad@ccml.fr    
Sub-Investigator: Saida Rezaiguia-Delclaux, MD, intensive care physician            
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue
Centre hospitalier Rene Dubos, 95303 Pontoise, France
CHUJean Minjoz, 25030 Besançon,France
CHU de Bordeaux,33604 PESSAC,France
University Hospital, Clermont-Ferrand
CHU de lyon, Hopital Louis Pradel,69500 Bron,France
Investigators
Principal Investigator: François STEPHAN, MD CCML
  More Information

No publications provided

Responsible Party: Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier: NCT01458444     History of Changes
Other Study ID Numbers: SC11-007, 2011-A00125-36
Study First Received: October 21, 2011
Last Updated: May 20, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

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

ClinicalTrials.gov processed this record on June 17, 2013