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

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

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

Sponsors & Collaborators

• University Hospital, Ghent

  lead OTHER

Principal Investigators

• Sunny Eloot, PhD, MScBME, MScCivE · University Hospital, Ghent

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-20

Primary Completion

2014-06-13

Completion

2014-09-12

Countries

• Belgium

Study Locations