Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 6, 2013
First Posted Date  ICMJE August 1, 2013
Last Update Posted Date June 3, 2015
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Determine the Optimal Operation Parameters During CO2 Removal With the Abylcap® System
Official Title  ICMJE Clinical Study to Determine the Optimal Operation Parameters During CO2 Removal With the Abylcap® System.
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • ARDS (Acute Respiratory Distress Syndrome)
  • Respiratory Acidosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Treatment with mechanical ventilation
Abylcap system with the oxygenator Lilliput2 as CO2 remover (Bellco, Italy).
Interventions:
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 31, 2013)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with ARDS and respiratory acidosis on the intensive care unit
  • Treated with the Abylcap system (Bellco, Italy)
  • Not pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01913977
Other Study ID Numbers  ICMJE 2013/386
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Ghent
Study Sponsor  ICMJE University Hospital, Ghent
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sunny Eloot, PhD, MScBME, MScCivE University Hospital, Ghent
PRS Account University Hospital, Ghent
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP