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| Name | Class |
|---|---|
| Charite University, Berlin, Germany | OTHER |
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A prospective, randomized study will be performed investigating the effects of a pumpless extracorporeal interventional lung assist [iLA] on the implementation of a lung-protective ventilatory strategy in patients with acute respiratory distress syndrome [ARDS] with a PaO2/FiO2 ratio < 200. The duration of ventilation, intensive care and hospital stay and in-hospital mortality will be investigated.
Evaluation group:
Implantation of the iLA - adaptation of the ventilation strategy, explantation of the iLA after corresponding improvement (see treatment plan for details) - weaning from the ventilation and extubation according to specified criteria.
Control group:
Ventilation strategy based on the concept of lung-protective ventilation without extracorporeal support, weaning from the ventilation and extubation according to specified criteria (see treatment plan for details).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Intervention: Implantation of the iLA - adaptation of the ventilation strategy, explantation of the iLA after corresponding improvement (see treatment plan for details) - weaning from the ventilation and extubation according to specified criteria. |
|
| 2 | Active Comparator | no device: Ventilation strategy based on the concept of lung-protective ventilation without extracorporeal support, weaning from the ventilation and extubation according to specified criteria (see treatment plan for details). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lung protective ventilation | Other | tidal volume 6 ml/kg ideal body weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator free days within 28 days after enrollment | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| hospital mortality, organ-failure free days, pulmonary gas exchange | 28 days - 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Bein, Professor Dr. | University Hospital Regensburg | Principal Investigator |
| Steffen Weber-Carstens, Dr. | Charite University Hospital Berlin | Study Chair |
| Thomas Staudinger, Prof | University Hospital Vienna, Austria | Study Chair |
| Sven Bercker, MD | University Hospital Leipzig, Germany | Study Chair |
| Ralph Müllenbach, MD PhD | University Hospital Würzburg, Germany | Study Chair |
| Rolf Dembinski, MD PhD | University Hospital Aachen, Germany | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Regensburg | Regensburg | 93042 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16540950 | Background | Bein T, Weber F, Philipp A, Prasser C, Pfeifer M, Schmid FX, Butz B, Birnbaum D, Taeger K, Schlitt HJ. A new pumpless extracorporeal interventional lung assist in critical hypoxemia/hypercapnia. Crit Care Med. 2006 May;34(5):1372-7. doi: 10.1097/01.CCM.0000215111.85483.BD. | |
| 23306584 | Derived | Bein T, Weber-Carstens S, Goldmann A, Muller T, Staudinger T, Brederlau J, Muellenbach R, Dembinski R, Graf BM, Wewalka M, Philipp A, Wernecke KD, Lubnow M, Slutsky AS. Lower tidal volume strategy ( approximately 3 ml/kg) combined with extracorporeal CO2 removal versus 'conventional' protective ventilation (6 ml/kg) in severe ARDS: the prospective randomized Xtravent-study. Intensive Care Med. 2013 May;39(5):847-56. doi: 10.1007/s00134-012-2787-6. Epub 2013 Jan 10. |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D000860 | Hypoxia |
| D006935 | Hypercapnia |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |