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

University of Regensburg120 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Acute Respiratory Distress Syndrome

Interventions

lung protective ventilationOTHER

tidal volume 6 ml/kg ideal body weight

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University Hospital Regensburg

Regensburg, Germany

Outcomes

Primary Outcomes

Ventilator free days within 28 days after enrollment

Time frame: 28 days

Secondary Outcomes

hospital mortality, organ-failure free days, pulmonary gas exchange

Time frame: 28 days - 60 days

Data from ClinicalTrials.gov

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