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Trial record 100 of 667 for:    CARBON DIOXIDE AND arterial

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

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ClinicalTrials.gov Identifier: NCT01913977
Recruitment Status : Unknown
Verified June 2015 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : August 1, 2013
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

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).


Condition or disease Intervention/treatment Phase
ARDS (Acute Respiratory Distress Syndrome) Respiratory Acidosis 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Determine the Optimal Operation Parameters During CO2 Removal With the Abylcap® System.
Study Start Date : June 2013
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : December 2015


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913977


Contacts
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Contact: Sunny Eloot, PhD, Engr. +32 93321025 Sunny.Eloot@ugent.be

Locations
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Belgium
Ghent University Hospital Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Contact: Sunny Eloot, PhD, MScBME, MScCivE    +32 9 3321025    Sunny.Eloot@ugent.be   
Principal Investigator: Sunny Eloot, PhD, MScBME, MScCivE         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Sunny Eloot, PhD, MScBME, MScCivE University Hospital, Ghent

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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01913977     History of Changes
Other Study ID Numbers: 2013/386
First Posted: August 1, 2013    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Acidosis, Respiratory
Acidosis
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Acid-Base Imbalance
Metabolic Diseases
Respiratory Insufficiency