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

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Other: lung protective ventilation

• Registration Number: NCT00538928
• Lead Sponsor: University of Regensburg

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).

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-02
• Study First Submitted QC: 2007-10-02
• Study First Posted: 2007-10-03
• Status Verified: 2009-03
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2011-03-01
• Last Update Posted: 2011-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	lung protective ventilation	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	lung protective ventilation	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).

Primary Outcome Measures

Name	Time	Method
Ventilator free days within 28 days after enrollment	28 days

Secondary Outcome Measures

Name	Time	Method
hospital mortality, organ-failure free days, pulmonary gas exchange	28 days - 60 days

Trial Locations

Locations (1)

University Hospital Regensburg; 🇩🇪 Regensburg, Germany