Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-01-14 @ 1:25 AM
Study NCT ID:
NCT00538928
Status:
COMPLETED
Last Update Posted:
2011-03-02
First Post:
2007-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extrapulmonary Interventional Ventilatory Support in Severe Acute Respiratory Distress Syndrome (ARDS)
Sponsor:
University of Regensburg
Organization:
Study Overview
Official Title:
Extrapulmonary Interventional Ventilatory Support for Lung Protection in Severe Acute Respiratory Distress - a Prospective Randomized Multi Centre Study
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Xtravent
Brief Summary:
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.
Detailed Description:
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).
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: