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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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).


Detailed Summary:
Sponsor: University Hospital, Ghent

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: University Hospital, Ghent

Dates:
Date Received: June 6, 2013
Date Started: June 2013
Date Completion: December 2015
Last Updated: June 2, 2015
Last Verified: June 2015