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 because the information has not been verified recently.
Verified February 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01296685
First received: February 14, 2011
Last updated: May 31, 2011
Last verified: February 2011
  Purpose

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.


Condition
Cardiovascular Surgical Procedure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Evaluation of Air Handling in Baby fx Oxygenator With Integrated Arterial Filter Versus Baby rx Oxygenator With Non Integrated Arterial Line Filter

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Estimated Enrollment: 40
Study Start Date: March 2011
Groups/Cohorts
oxygenator with arterial filter
arterial filter

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296685

Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Layth Al Tmimi, Dr. University Hospitals Leuven
  More Information

No publications provided

Responsible Party: Dr. Al Tmimmi, University Hospitals Leuven
ClinicalTrials.gov Identifier: NCT01296685     History of Changes
Other Study ID Numbers: S 52937
Study First Received: February 14, 2011
Last Updated: May 31, 2011
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
cardiovascular surgical procedure

ClinicalTrials.gov processed this record on September 16, 2014