Protective Ventilation With Carbon Dioxide (CO2) -Removal Technique in Patients With Adult Respiratory Distress Syndrome (ARDS)
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|ClinicalTrials.gov Identifier: NCT00465309|
Recruitment Status : Completed
First Posted : April 25, 2007
Last Update Posted : January 12, 2009
30% of ARDS patients ventilated according to NIH protocol presents morphological (CT) and functional (Stress Index>1) conditions of hyperinflation even with Plateau pressure (Pplat) < 30 cmH2O; values of Pplat lower than 26 cmH2O were associated with more a condition of more protective ventilation.
In patients at risk of hyperinflation, use of alternative techniques such as CO2-removal my allow the reduction of Tidal Volume (Vt) and Pplat.
|Condition or disease||Intervention/treatment||Phase|
|Adult Respiratory Distress Syndrome||Procedure: protective ventilation with CO2 removal technique||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||April 2007|
|Actual Study Completion Date :||November 2008|
- Procedure: protective ventilation with CO2 removal technique
In ARDS patients, presenting a Pplat ≥ 26 cmH2O, Vt was lowered (reaching a Pplat < 26) with CO2-removal veno-venous pump-driven bypass support for 48 consecutive hours with a pH > 7,30 or at least 72 hours from the beginning of the extracorporeal treatment.
- pulmonary inflammatory mediator reduction [ Time Frame: within the first 72 hours after enrollment ]
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): NCT00465309
|University of Turin, Department of Anesthesia and Intensive Care Medicine,S. G. Battista Hospital|
|Turin, Italy, 10126|
|University of Turin, Department of Anesthesia and Intensive Care Medicine|
|Turin, Italy, 10126|
|Study Director:||V. M. Ranieri, MD||University of Turin, Italy|
|Principal Investigator:||P. Terragni, MD||University of Turin, Italy|