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

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 |
- 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
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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

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
France | |
Centre Chirurgical MarieLannelongue | |
Le Plessis Robinson, Ile de France, France, 92350 |
Principal Investigator: | François STEPHAN, MD | CCML |
Responsible Party: | Centre Chirurgical Marie Lannelongue |
ClinicalTrials.gov Identifier: | NCT01458444 |
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 |
Respiratory Insufficiency Cardiothoracic Surgery Ventilation system |
Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases |