- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01458444
BIPAP Vision Versus OPTIFLOW System Comparison in Acute Respiratory Failure After Cardio Thoracic Surgery (OPTIFLOW)
Acute Respiratory Failure After Cardio Thoracic Surgery: Non Invasive Ventilation (VNI) by BIPAP Vision Versus OPTIFLOW System, Comparison.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ile de France
-
Le Plessis Robinson, Ile de France, France, 92350
- Centre Chirurgical MarieLannelongue
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: BIPAP
Non invasive ventilation (VNI) by BIPAP® vision
|
BIPAP® vision
|
EXPERIMENTAL: OPTIFLOW
OPTIFLOW system
|
OPTIFLOW system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
One week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sensation of dyspnea
Time Frame: one week
|
one week
|
Skin tolerance and comfort
Time Frame: One week
|
One week
|
Evolution of hemodynamic and respiratory parameters
Time Frame: one week
|
one week
|
number of bronchoscopy performed during the patient's stay in Intensive Care Unit
Time Frame: one week
|
one week
|
number of postoperative pneumonia and antibiotic use
Time Frame: one week
|
one week
|
length of stay in intensive care
Time Frame: one week
|
one week
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: François STEPHAN, MD, CCML
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SC11-007
- 2011-A00125-36 (OTHER: ANSM)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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