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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-01-31

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.

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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).

Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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.

Group Type EXPERIMENTAL

lung protective ventilation

Intervention Type OTHER

tidal volume 6 ml/kg ideal body weight

2

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).

Group Type ACTIVE_COMPARATOR

lung protective ventilation

Intervention Type OTHER

tidal volume 6 ml/kg ideal body weight

Interventions

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lung protective ventilation

tidal volume 6 ml/kg ideal body weight

Intervention Type OTHER

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No