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NCT Number: NCT01913977

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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

Device

Abylcap settings

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

Device

Abylcap settings

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

Device

Abylcap settings

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

Device

Abylcap settings

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

Device

Abylcap settings

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

Device

Abylcap settings

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

Device

Abylcap settings

Primary outcomes

  1. calculation of CO2 extraction in blood samples during mechanical ventilation

    Time frame: during 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 outcomes

  1. Based on the extraction rates, the optimum parameter settings are derived

    Time frame: During 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 1, 2013
Registry last updated
Dec 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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