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BIPAP Vision Versus OPTIFLOW System Comparison in Acute Respiratory Failure After Cardio Thoracic Surgery (OPTIFLOW)
This study has been completed.
Sponsor:
Centre Chirurgical Marie Lannelongue
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
ClinicalTrials.gov Identifier:
NCT01458444
First received: October 21, 2011
Last updated: August 30, 2015
Last verified: August 2015
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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 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:
MedlinePlus related topics:
Respiratory Failure
Genetic and Rare Diseases Information Center resources:
Respiratory Distress Syndrome, Infant
Acute Respiratory Distress Syndrome
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 ]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 ]
- Skin tolerance and comfort [ Time Frame: One week ]
- Evolution of hemodynamic and respiratory parameters [ Time Frame: one week ]
- number of bronchoscopy performed during the patient's stay in Intensive Care Unit [ Time Frame: one week ]
- number of postoperative pneumonia and antibiotic use [ Time Frame: one week ]
- length of stay in intensive care [ Time Frame: one week ]
| 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 (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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01458444
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
Hopital Jean Minjoz
University Hospital, Bordeaux
University Hospital, Clermont-Ferrand
Hopital Louis Pradel
Investigators
| Principal Investigator: | François STEPHAN, MD | CCML |
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 ) |
| Study First Received: | October 21, 2011 |
| Last Updated: | August 30, 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 |
ClinicalTrials.gov processed this record on July 25, 2017