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

Respiratory Acidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01913977
• Other study ID #: 2013/386
• Status: Completed
• Phase: N/A
• Start date: February 20, 2014
• Est. completion date: September 12, 2014

Study information

• Verified date: December 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: September 12, 2014
• Est. primary completion date: June 13, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Acidosis
• Acute Lung Injury
• ARDS (Acute Respiratory Distress Syndrome)
• Respiratory Acidosis
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Gent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Based on the extraction rates, the optimum parameter settings are derived	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)