Clinical Study to Determine the Optimal Operation Parameters During CO2 Removal With the Abylcap® System

Study Overview
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Brief Summary
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This prospective study includes 5 patients with ARDS (Acute Respiratory Distress Syndrome) treated by mechanical ventilation. In case of respiratory acidosis, extracorporeal CO2 (carbon dioxide)removal might be necessary. We hereby work with the Abylcap system with the oxygenator Lilliput2 as CO2 remover (Bellco, Italy). The patients (M/V) are older than 18, not pregnant, have a BMI<30, and no contraindication for anticoagulation therapy. Under standard conditions patients are treated with a blood flow of QB=300mL/min and a gas flow (100% 02) of QG=7L/min. Blood sampling is performed from the arterial bloodline in the patients at 0, 1h, 3h, 24h, 48h, 72h, 96h, and 120h. A parameter study is also performed to optimise CO2 removal. Herewith, blood samples (1mL) are taken from the inlet and outlet line of the Lilliput2 at the previously mentioned time points and for different flow setting: Blood flow (QB) 200-300-400mL/min and gas flow (QG) 1.5, 3, 6, 7, 8L/min Blood samples are analysed for the different blood gases from which the extraction in the CO2 remover can be calculated for each setting of QB (blood flow) and QG (gas flow).

Official Title
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Clinical Study to Determine the Optimal Operation Parameters During CO2 Removal With the Abylcap® System.

Conditions
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ARDS (Acute Respiratory Distress Syndrome), Respiratory Acidosis

Intervention / Treatment
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* Device: Abylcap® System: blood flow (QB): 200mL/min; gas flow (QG):7L/min
* Device: Abylcap® System: blood flow (QB): 300mL/min; gas flow (QG):7L/min
* Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):7L/min
* Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):1.5L/min
* Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):3L/min
* Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):6L/min
* Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):8L/min


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ARDS and respiratory acidosis on the intensive care unit Treated with the Abylcap system (Bellco, Italy) Not pregnant

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: Treatment with mechanical ventilation<br>Abylcap system with the oxygenator Lilliput2 as CO2 remover (Bellco, Italy). | Device: Abylcap® System: blood flow (QB): 200mL/min; gas flow (QG):7L/min<br>* Abylcap settings<br>Device: Abylcap® System: blood flow (QB): 300mL/min; gas flow (QG):7L/min<br>* Abylcap settings<br>Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):7L/min<br>* Abylcap settings<br>Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):1.5L/min<br>* Abylcap settings<br>Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):3L/min<br>* Abylcap settings<br>Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):6L/min<br>* Abylcap settings<br>Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):8L/min<br>* Abylcap settings<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| calculation of CO2 extraction in blood samples during mechanical ventilation | Extraction is calculated from the relative difference in blood gases at the inlet and outlet of the CO2 remover. | during mechanical ventilation with CO2 removal (max up to 120h) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Based on the extraction rates, the optimum parameter settings are derived | Extraction is calculated from the relative difference in blood gases at the inlet and outlet of the CO2 remover. | During mechanical ventilation with CO2 removal (max up to 120h) |