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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Extracorporeal Lung Assist to Avoid Intubation in Patients Failing Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure

Conditions
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Hypercapnia, Respiratory Insufficiency

Intervention / Treatment
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* Device: vv-ECCO2R (Novalung GmbH, Germany)


Participation Criteria
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Eligibility Criteria
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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: under 18 years of age prior inclusion in other interventional study pregnancy heparin allergy or heparin-induced thrombocytopenia type 2 on home non-invasive ventilator Do not resuscitate order or moribund condition life expectancy less than 6 months no informed consent available

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECLA-group<br>Treatment with a pump driven, venovenous extracorporeal lung assist | Device: vv-ECCO2R (Novalung GmbH, Germany)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of intubation for invasive mechanical ventilation | Rate of intubation for invasive mechanical ventilation | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of non-invasive ventilation | Length of non-invasive ventilation | 21 days | 
| Complication rates | Any 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 | 3 months | 
| Length of invasive mechanical ventilation if intubated | Length of invasive mechanical ventilation if intubated | 3 months | 
| Length of stay in ICU and hospital | Length of stay in ICU and hospital | 3 months | 
| Mortality | 3-months-mortality | 3 months | 
| Changes in blood gases and respiratory rate pre/post start of ECLA | Changes in arterial blood gases before and after the initiation of the pump driven extracorporeal lung assist | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypercapnia, noninvasive ventilation, acute respiratory failure, endotracheal intubation, invasive mechanical ventilation