- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01256333
Optimization of Arterial Oxygen Transport by Positive End-expiratory Pressure Variation in Acute Respiratory Distress Syndrome (OPTIPEP)
Despite improving in the treatment of acute respiratory distress syndrome (ARDS), this affection keep an elevate rate of death. The strategy of mechanical ventilation is more and more under definite protocol, following large strength randomized studies. Although, it doesn't exist today element allowing to adjust the level of Positive End-Expiratory Pressure (PEEP) with improvement in patient's survival.
The investigators proposed in this study to determinate the level of PEEP adjust to obtain the better arterial oxygen transport (TaO2). The investigators going to conduct a physiologic, observational, none controlled study. All patients hospitalized in intensive care unit of Pontchaillou hospital with ARDS criteria and without specific exclusion criteria will be included. Primary objective is to looking for the optimum level of PEEP for TaO2.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Aquitaine
-
Perigueux, Aquitaine, France, 24019
- Perigueux Hospital
-
-
Britanny
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Rennes, Britanny, France, 35033
- Rennes University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patient presenting a Acute Respiratory Distress Syndrone (ARDS) definite by : acute respiratory failure, bilateral alveolo-interstitial infiltrate on chest radiography, absence of increased left ventricular filling pressure, partial pressure of oxygen in arterial blood (PaO2)/Fraction of inspired oxygen(FiO2) <200 and Positive End-Expiratory Pressure (PEEP) > or equal to 5 cmH2O
- Need to invasive mechanical ventilation
- Precedent criteria persisting at least 6 hours
- Haemoglobin > 8g/dl
- Ramsay score at 6
Exclusion Criteria:
- Participation to en other study on the Acute Respiratory Distress Syndrone (ARDS) with the same end-point
- Presence of external circulatory assist
- Left Ventricular Ejection fraction (LVEF)or Left ventricular shortening fraction (LVSF)< 40% after correction of hypovolemia and/or vasoplegia
- Infusion of inotrope
- Presence of Acute Pulmonary Heart
- Following procedure : ExtraCorporeal Membrane Oxygenation(ECMO), prone position, inhalation of Nitrogen dioxyde
- Presence of a chest tube
- Pregnant or nursing mother
- Less than 18 years old
- Complete arrhythmia by atrial fibrillation
- Person under justice protection
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determinate the Positive End-Expiratory Pressure (PEEP) level achieving the best arterial oxygen transport (TaO2)
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evolution of pulmonary gas exchanges
Time Frame: 1 year
|
1 year
|
Evolution of respiratory mechanism parameters
Time Frame: 1 year
|
1 year
|
evolution of circulatory parameters and needs of catecholamine during the study
Time Frame: 1 year
|
1 year
|
Appearance of secondary effects due to mechanical ventilation
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Loic Chimot, CH de Périgueux
Study record dates
Study Major Dates
Study Start
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
- 2010-A00942-37
- LOC/10-08
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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