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

G

Ghent University Hospital (UZ)

Status

Completed

Conditions

ARDS (Acute Respiratory Distress Syndrome)
Respiratory Acidosis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01913977
2013/386

Details and patient eligibility

About

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).

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

4 participants in 1 patient group

Treatment with mechanical ventilation
Experimental group
Description:
Abylcap system with the oxygenator Lilliput2 as CO2 remover (Bellco, Italy).
Treatment:
Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):3L/min
Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):8L/min
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):6L/min
Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):1.5L/min

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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