Extrapulmonary Interventional Ventilatory Support in Severe Acute Respiratory Distress Syndrome (ARDS) (Xtravent)
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ClinicalTrials.gov Identifier: NCT00538928 |
Recruitment Status
:
Completed
First Posted
: October 3, 2007
Last Update Posted
: March 2, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Respiratory Distress Syndrome | Other: lung protective ventilation | Not Applicable |
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).
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Extrapulmonary Interventional Ventilatory Support for Lung Protection in Severe Acute Respiratory Distress - a Prospective Randomized Multi Centre Study |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | January 2011 |
Actual Study Completion Date : | January 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
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.
|
Other: lung protective ventilation
tidal volume 6 ml/kg ideal body weight
|
Active Comparator: 2
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).
|
Other: lung protective ventilation
tidal volume 6 ml/kg ideal body weight
|
- Ventilator free days within 28 days after enrollment [ Time Frame: 28 days ]
- hospital mortality, organ-failure free days, pulmonary gas exchange [ Time Frame: 28 days - 60 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The trial subjects are patients aged 18 years or older who have developed severe ARDS. Following the American-European Consensus Conference on ARDS, severe ARDS is defined as an oxygenation index (PaO2/FIO2) < 200 mmHg. These parameters must be present for a duration of at least 2 hours.
Exclusion Criteria:
- age < 18 years
- decompensated heart insufficiency
- acute coronary syndrome
- severe chronic obstructive pulmonary disease
- advanced tumour conditions with life expectancy < 6 months
- chronic dialysis treatment
- lung transplant patients
- proven Heparin-induced thrombocytopenia (HIT)
- morbid obesity (BMI >) 40
- Child Class B and C cirrhosis of the liver, acute fulminant hepatic failure
- severe peripheral arterial occlusive disease (pAVK III - IV), absence of limb doppler pulse
- brain injury (GCS < 9 + CT pathology)

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): NCT00538928
Germany | |
University Hospital Regensburg | |
Regensburg, Germany, 93042 |
Principal Investigator: | Thomas Bein, Professor Dr. | University Hospital Regensburg | |
Study Chair: | 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 |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Department of Anesthesia, University Hospital |
ClinicalTrials.gov Identifier: | NCT00538928 History of Changes |
Other Study ID Numbers: |
KKS 4012-001-07 |
First Posted: | October 3, 2007 Key Record Dates |
Last Update Posted: | March 2, 2011 |
Last Verified: | March 2009 |
Keywords provided by University of Regensburg:
acute respiratory distress syndrome extracorporeal lung support hypoxia hypercapnia acute respiratory distress syndrome (ARDS) |
Additional relevant MeSH terms:
Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Disease Pathologic Processes |
Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury |