NCT00538928

Extrapulmonary Interventional Ventilatory Support in Severe Acute Respiratory Distress Syndrome (ARDS)

Extrapulmonary Interventional Ventilatory Support for Lung Protection in Severe Acute Respiratory Distress - a Prospective Randomized Multi Centre Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Regensburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
OTHER	lung protective ventilation	tidal volume 6 ml/kg ideal body weight

Timeline

• Start date: 2007-09-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2007-10-03
• Last updated: 2011-03-02

Locations

1 site across 1 country: Germany