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

Not Applicable

Completed

• Conditions: Respiratory Acidosis; ARDS (Acute Respiratory Distress Syndrome)

• Registration Number: NCT01913977
• Lead Sponsor: University Hospital, Ghent

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 Description

Not available

Study Timeline

• Study First Submitted: 2013-06-06
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-01
• Study Start: 2014-02-20
• Primary Completion: 2014-06-13
• Study Completion: 2014-09-12
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-28
• Last Update Posted: 2022-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
calculation of CO2 extraction in blood samples during mechanical ventilation	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 Outcome Measures

Name	Time	Method
Based on the extraction rates, the optimum parameter settings are derived	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.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Gent, Oost-Vlaanderen, Belgium