The study´s intention is to evaluate the feasibility, safety and effectiveness of a pump driven extracorporeal device for removal of carbon dioxide from the blood in oder to avoid intubation and invasive mechanical ventilation in patients with acute respiratory failure retaining carbon dioxide due to the failure of their ventilatory muscle pump and not responding to prior non-invasive mask ventilation.
The study´s intention is to evaluate the feasibility, safety and effectiveness of a pump driven extracorporeal device for removal of carbon dioxide from the blood in oder to avoid intubation and invasive mechanical ventilation in patients with acute respiratory failure retaining carbon dioxide due to the failure of their ventilatory muscle pump and not responding to prior non-invasive mask ventilation. Since intubation with subsequent (prolonged) invasive mechanical ventilation is associated with considerable side effects this new strategy has the potential to improve overall clinical outcome in this selected patient group.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Treatment with the extracorporeal lung assist (ECLA) The ECLA is a pump driven (centrifugal pump) venovenous circuit, which removes carbon dioxide from the patients blood by means of a membrane through which the patients blood runs on the one side of the membrane and sweep gas on the other side removing the patient´s carbon dioxide. Blood flow range from 0.5 to 4.5 l/min and sweep gas flow between 1 and 10 l/min. At blood flows of 2 l/min and higher the device also oxygenates the patients blood. The diameter and length of cannulas and the sites of venous insertions are left to the decision of the treating physician. Cannulas are inserted in seldinger technique under sterile conditions. Function and patency of the extracorporeal circuit requires mild therapeutic anticoagulation.
Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf (plus 10 further centres in Germany, Austria and the Netherlands)
Hamburg, Germany
Number of Patients With Need for Intubation for Invasive Mechanical Ventilation
The number of patients in the ECLA-group who had to be intubated and mechanically ventilated under the given criteria for inclusion and exclusion is collected. Since every patient in the matched control group was intubated, the comparison of the groups shows whether the use of a pump-driven venovenous extracorporeal lung assist can reduce the frequency of intubation and mechanical ventilation.
Time frame: 21 days
Length of Non-invasive Ventilation
The duration of non-invasive ventilation up to day 90 is used to evaluate the respiratory outcomes of ECLA versus invasive mechanical ventilation.
Time frame: 90 days
Complication Rates
Major complication associated with the pump driven extracorporeal lung assist device or with non-invasive or invasive mechanical ventilation or any associated treatments during the observational period
Time frame: 90 days
Length of Invasive Mechanical Ventilation if Intubated
Describes the length of invasive mechanical ventilation in days, in case intubation and mechanical ventilation became necessary
Time frame: 90 days
Length of Stay in ICU
Describes the length of stay in ICU
Time frame: 90 days
Mortality
Comparison of 90-day mortality between the study arms. Seven patients died in each of the two arms after 90 days, so the stated values are correct.
Time frame: 90 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.