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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01913977
Enrollment
4
Registered
2013-08-01
Start date
2014-02-20
Completion date
2014-09-12
Last updated
2022-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS (Acute Respiratory Distress Syndrome), Respiratory Acidosis

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).

Interventions

DEVICEAbylcap® System: blood flow (QB): 200mL/min; gas flow (QG):7L/min

Abylcap settings

DEVICEAbylcap® System: blood flow (QB): 300mL/min; gas flow (QG):7L/min

Abylcap settings

DEVICEAbylcap® System: blood flow (QB): 400mL/min; gas flow (QG):7L/min

Abylcap settings

DEVICEAbylcap® System: blood flow (QB): 400mL/min; gas flow (QG):1.5L/min

Abylcap settings

DEVICEAbylcap® System: blood flow (QB): 400mL/min; gas flow (QG):3L/min

Abylcap settings

DEVICEAbylcap® System: blood flow (QB): 400mL/min; gas flow (QG):6L/min

Abylcap settings

DEVICEAbylcap® System: blood flow (QB): 400mL/min; gas flow (QG):8L/min

Abylcap settings

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with ARDS and respiratory acidosis on the intensive care unit * Treated with the Abylcap system (Bellco, Italy) * Not pregnant

Design outcomes

Primary

MeasureTime frameDescription
calculation of CO2 extraction in blood samples during mechanical ventilationduring mechanical ventilation with CO2 removal (max up to 120h)Extraction is calculated from the relative difference in blood gases at the inlet and outlet of the CO2 remover.

Secondary

MeasureTime frameDescription
Based on the extraction rates, the optimum parameter settings are derivedDuring mechanical ventilation with CO2 removal (max up to 120h)Extraction is calculated from the relative difference in blood gases at the inlet and outlet of the CO2 remover.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026