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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

U

Universitaire Ziekenhuizen KU Leuven

Status

Unknown

Conditions

Cardiovascular Surgical Procedure

Study type

Observational

Funder types

Other

Identifiers

NCT01296685
S 52937

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

40 participants in 2 patient groups

oxygenator with arterial filter
arterial filter

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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