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NCT Number: NCT00538928

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

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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Key information

Conditions

Acute Respiratory Distress Syndrome Hypercapnia Hypoxia Lung Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Regensburg

Regensburg, 93042, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lung Protective Ventilation

Other

tidal volume 6 ml/kg ideal body weight

Primary outcomes

  1. Ventilator free days within 28 days after enrollment

    Time frame: 28 days

Secondary outcomes

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

    Time frame: 28 days - 60 days

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Collaborators

  • Charite University, Berlin, Germany

Registry information

Official study title

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

Acronym: Xtravent

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Oct 3, 2007
Registry last updated
Mar 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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