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

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

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).

Study Overview

• Status: Completed
• Conditions: ARDS (Acute Respiratory Distress Syndrome); Respiratory Acidosis
• Intervention / Treatment: Device: Abylcap® System: blood flow (QB): 200mL/min; gas flow (QG):7L/min; Device: Abylcap® System: blood flow (QB): 300mL/min; gas flow (QG):7L/min; Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):7L/min; Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):1.5L/min; Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):3L/min; Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):6L/min; Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):8L/min

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Sunny Eloot, PhD, MScBME, MScCivE, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2014
• Primary Completion (Actual): June 13, 2014
• Study Completion (Actual): September 12, 2014

Study Registration Dates

• First Submitted: June 6, 2013
• First Submitted That Met QC Criteria: July 31, 2013
• First Posted (Estimate): August 1, 2013

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Respiratory Insufficiency; Infant, Premature, Diseases; Acid-Base Imbalance; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Acidosis; Acidosis, Respiratory
• Other Study ID Numbers: 2013/386