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

University of Regensburg1 site in 1 country120 target enrollmentSeptember 2007

ConditionsAcute Respiratory Distress Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Respiratory Distress Syndrome
Sponsor: University of Regensburg
Enrollment: 120
Locations: 1
Primary Endpoint: Ventilator free days within 28 days after enrollment
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

January 2011

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Regensburg

Eligibility Criteria

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.