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Clinical Evaluation of Air Handling in Baby fx Oxygenator With Integrated Arterial Filter Versus Baby rx Oxygenator With Non Integrated Arterial Line Filter

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01296685
First Posted: February 15, 2011
Last Update Posted: June 1, 2011
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.
Information provided by:
Universitaire Ziekenhuizen Leuven
February 14, 2011
February 15, 2011
June 1, 2011
March 2011
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Complete list of historical versions of study NCT01296685 on ClinicalTrials.gov Archive Site
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Clinical Evaluation of Air Handling in Baby fx Oxygenator With Integrated Arterial Filter Versus Baby rx Oxygenator With Non Integrated Arterial Line Filter
Clinical Evaluation of Air Handling in Baby fx Oxygenator With Integrated Arterial Filter Versus Baby rx Oxygenator With Non Integrated Arterial Line Filter
The goal of the study is the evaluation of the air handling of a "new" type of oxygenator versus the standard model. The new type has an integrated arterial filter. The standard model has a non integrated arterial line filter. If the air handling is as effective/ better than in the standard model this can lead to reduction of cardiopulmonary bypass circuits with their initiation of systemic inflammatory response and improve cardiopulmonary bypass safety.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
All children with body surface area between 0.25 and 0.5 m² who need cardiac surgery with cardiopulmonary bypass. Urgent and norwood procedures are excluded.
Cardiovascular Surgical Procedure
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  • oxygenator with arterial filter
  • arterial filter
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
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Inclusion Criteria:

  • All children with body surface area between 0.25 and 0.5 m² who need cardiac surgery with cardiopulmonary bypass.

Exclusion Criteria:

  • Urgent and norwood procedures.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Belgium
 
NCT01296685
S 52937
Yes
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Dr. Al Tmimmi, University Hospitals Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Principal Investigator: Layth Al Tmimi, Dr. University Hospitals Leuven
Universitaire Ziekenhuizen Leuven
February 2011