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

NCT01296685 | Unknown DMC

• 1 other identifier: S 52937
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Surgical Procedure

Keywords

cardiovascular surgical procedure

Study Arms (2)

oxygenator with arterial filter

arterial filter

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Urgent and norwood procedures.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Officials

• Layth Al Tmimi, Dr.

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: February 15, 2011
• Study Start: March 1, 2011
• Last Updated: June 1, 2011

Record last verified: 2011-02