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

Overview

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).

Full Title of Study: “Clinical Study to Determine the Optimal Operation Parameters During CO2 Removal With the Abylcap® System.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 13, 2014

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Treatment with mechanical ventilation
    • Abylcap system with the oxygenator Lilliput2 as CO2 remover (Bellco, Italy).

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Ghent
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sunny Eloot, PhD, MScBME, MScCivE, Principal Investigator, University Hospital, Ghent

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