Brief Summary

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

7 months study duration

First Submitted

Initial submission to the registry

June 6, 2013

Completed

2 months until next milestone

First Posted

Study publicly available on registry

August 1, 2013

Completed

7 months until next milestone

Study Start

First participant enrolled

February 20, 2014

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2014

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2014

Completed

Last Updated

December 29, 2022

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

June 6, 2013

Last Update Submit

December 28, 2022

Conditions

ARDS (Acute Respiratory Distress Syndrome)Respiratory Acidosis

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

Based on the extraction rates, the optimum parameter settings are derived
During mechanical ventilation with CO2 removal (max up to 120h)

Study Arms (1)

Treatment with mechanical ventilation

EXPERIMENTAL

Abylcap system with the oxygenator Lilliput2 as CO2 remover (Bellco, Italy).

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