Extracorporeal Lung Assist to Avoid Intubation in Patients Failing Noninvasive Ventilation for Hypercapnic ARF

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

acute or acute-on-chronic hypercapnic respiratory insufficiency (pH ≤ 7,35, PaCO2 > 45 mmHg)
failure of noninvasive ventilation
fulfilling criteria for endotracheal intubation

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
ECLA-group	vv-ECCO2R (Novalung GmbH, Germany)	Treatment with a pump driven, venovenous extracorporeal lung assist

Primary Outcome Measures

Name	Time	Method
Number of Patients With Need for Intubation for Invasive Mechanical Ventilation	21 days	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.

Secondary Outcome Measures

Name	Time	Method
Length of Non-invasive Ventilation	90 days	The duration of non-invasive ventilation up to day 90 is used to evaluate the respiratory outcomes of ECLA versus invasive mechanical ventilation.
Mortality	90 days	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.
Complication Rates	90 days	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
Length of Invasive Mechanical Ventilation if Intubated	90 days	Describes the length of invasive mechanical ventilation in days, in case intubation and mechanical ventilation became necessary
Length of Stay in ICU	90 days	Describes the length of stay in ICU

Locations (1): Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf (plus 10 further centres in Germany, Austria and the Netherlands)
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Hamburg, Germany