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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Other: lung protective ventilation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* tidal volume 6 ml/kg ideal body weight<br>|
| Active Comparator: 2<br>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<br>* tidal volume 6 ml/kg ideal body weight<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator free days within 28 days after enrollment |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital mortality, organ-failure free days, pulmonary gas exchange |  | 28 days - 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute respiratory distress syndrome, extracorporeal lung support, hypoxia, hypercapnia, acute respiratory distress syndrome (ARDS)