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

• Conditions: Cardiovascular Surgical Procedure

• Registration Number: NCT01296685
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-02
• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-02-14
• Study First Posted: 2011-02-15
• Study Start: 2011-03
• Last Update Submitted: 2011-05-31
• Last Update Posted: 2011-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified