Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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
Hopital Louis Pradel
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
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 ]
Enrollment: 830
Study Start Date: May 2011
Study Completion Date: January 2014
Primary Completion Date: January 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
CHUJean Minjoz, 25030 Besançon,France
CHU de Bordeaux,33604 PESSAC,France
University Hospital, Clermont-Ferrand
Hopital Louis Pradel
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: January 23, 2014
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
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on March 01, 2015