NCT01913977

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• ARDS (Acute Respiratory Distress Syndrome)
• Respiratory Acidosis

Interventions

Type	Name	Description
DEVICE	Abylcap® System: blood flow (QB): 200mL/min; gas flow (QG):7L/min	Abylcap settings
DEVICE	Abylcap® System: blood flow (QB): 300mL/min; gas flow (QG):7L/min	Abylcap settings
DEVICE	Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):7L/min	Abylcap settings
DEVICE	Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):1.5L/min	Abylcap settings
DEVICE	Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):3L/min	Abylcap settings
DEVICE	Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):6L/min	Abylcap settings
DEVICE	Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):8L/min	Abylcap settings

Timeline

• Start date: 2014-02-20
• Primary completion: 2014-06-13
• Completion: 2014-09-12
• First posted: 2013-08-01
• Last updated: 2022-12-29

Locations

1 site across 1 country: Belgium