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

University of Regensburg (UR)

Status: Completed

Conditions: Acute Respiratory Distress Syndrome

Treatments: Other: lung protective ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT00538928

KKS 4012-001-07

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Other: lung protective ventilation

2

Active Comparator group

Description:

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).

Treatment:

Other: lung protective ventilation