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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00538928

Acronym

Xtravent

Enrollment

120

Registered

2007-10-03

Start date

2007-09-30

Completion date

2011-01-31

Last updated

2011-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

Keywords

acute respiratory distress syndrome, extracorporeal lung support, hypoxia, hypercapnia, acute respiratory distress syndrome (ARDS)

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).

Interventions

OTHERlung protective ventilation

tidal volume 6 ml/kg ideal body weight

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
Ventilator free days within 28 days after enrollment	28 days

Secondary

Measure	Time frame
hospital mortality, organ-failure free days, pulmonary gas exchange	28 days - 60 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026