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

Primary Purpose

ARDS (Acute Respiratory Distress Syndrome), Respiratory Acidosis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Abylcap® System: blood flow (QB): 200mL/min; gas flow (QG):7L/min
Abylcap® System: blood flow (QB): 300mL/min; gas flow (QG):7L/min
Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):7L/min
Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):1.5L/min
Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):3L/min
Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):6L/min
Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):8L/min
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ARDS (Acute Respiratory Distress Syndrome)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Ghent University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with mechanical ventilation

Arm Description

Abylcap system with the oxygenator Lilliput2 as CO2 remover (Bellco, Italy).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 6, 2013
Last Updated
December 28, 2022
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT01913977
Brief Title
Clinical Study to Determine the Optimal Operation Parameters During CO2 Removal With the Abylcap® System
Official Title
Clinical Study to Determine the Optimal Operation Parameters During CO2 Removal With the Abylcap® System.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 20, 2014 (Actual)
Primary Completion Date
June 13, 2014 (Actual)
Study Completion Date
September 12, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS (Acute Respiratory Distress Syndrome), Respiratory Acidosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with mechanical ventilation
Arm Type
Experimental
Arm Description
Abylcap system with the oxygenator Lilliput2 as CO2 remover (Bellco, Italy).
Intervention Type
Device
Intervention Name(s)
Abylcap® System: blood flow (QB): 200mL/min; gas flow (QG):7L/min
Intervention Description
Abylcap settings
Intervention Type
Device
Intervention Name(s)
Abylcap® System: blood flow (QB): 300mL/min; gas flow (QG):7L/min
Intervention Description
Abylcap settings
Intervention Type
Device
Intervention Name(s)
Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):7L/min
Intervention Description
Abylcap settings
Intervention Type
Device
Intervention Name(s)
Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):1.5L/min
Intervention Description
Abylcap settings
Intervention Type
Device
Intervention Name(s)
Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):3L/min
Intervention Description
Abylcap settings
Intervention Type
Device
Intervention Name(s)
Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):6L/min
Intervention Description
Abylcap settings
Intervention Type
Device
Intervention Name(s)
Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):8L/min
Intervention Description
Abylcap settings
Primary Outcome Measure Information:
Title
calculation of CO2 extraction in blood samples during mechanical ventilation
Description
Extraction is calculated from the relative difference in blood gases at the inlet and outlet of the CO2 remover.
Time Frame
during mechanical ventilation with CO2 removal (max up to 120h)
Secondary Outcome Measure Information:
Title
Based on the extraction rates, the optimum parameter settings are derived
Description
Extraction is calculated from the relative difference in blood gases at the inlet and outlet of the CO2 remover.
Time Frame
During mechanical ventilation with CO2 removal (max up to 120h)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with ARDS and respiratory acidosis on the intensive care unit Treated with the Abylcap system (Bellco, Italy) Not pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunny Eloot, PhD, MScBME, MScCivE
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

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

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