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

NCT ID: NCT01913977

Last Updated: 2022-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-20

Study Completion Date

2014-09-12

Brief Summary

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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

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Conditions

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ARDS (Acute Respiratory Distress Syndrome) Respiratory Acidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with mechanical ventilation

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

Group Type EXPERIMENTAL

Abylcap® System: blood flow (QB): 200mL/min; gas flow (QG):7L/min

Intervention Type DEVICE

Abylcap settings

Abylcap® System: blood flow (QB): 300mL/min; gas flow (QG):7L/min

Intervention Type DEVICE

Abylcap settings

Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):7L/min

Intervention Type DEVICE

Abylcap settings

Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):1.5L/min

Intervention Type DEVICE

Abylcap settings

Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):3L/min

Intervention Type DEVICE

Abylcap settings

Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):6L/min

Intervention Type DEVICE

Abylcap settings

Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):8L/min

Intervention Type DEVICE

Abylcap settings

Interventions

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Abylcap® System: blood flow (QB): 200mL/min; gas flow (QG):7L/min

Abylcap settings

Intervention Type DEVICE

Abylcap® System: blood flow (QB): 300mL/min; gas flow (QG):7L/min

Abylcap settings

Intervention Type DEVICE

Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):7L/min

Abylcap settings

Intervention Type DEVICE

Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):1.5L/min

Abylcap settings

Intervention Type DEVICE

Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):3L/min

Abylcap settings

Intervention Type DEVICE

Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):6L/min

Abylcap settings

Intervention Type DEVICE

Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):8L/min

Abylcap settings

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sunny Eloot, PhD, MScBME, MScCivE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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Ghent University Hospital

Ghent, Oost-Vlaanderen, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2013/386

Identifier Type: -

Identifier Source: org_study_id