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

May 31, 2011 updated by: Universitaire Ziekenhuizen KU Leuven
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
oxygenator with arterial filter
arterial filter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Layth Al Tmimi, Dr., Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Study Registration Dates

First Submitted

February 14, 2011

First Submitted That Met QC Criteria

February 14, 2011

First Posted (Estimate)

February 15, 2011

Study Record Updates

Last Update Posted (Estimate)

June 1, 2011

Last Update Submitted That Met QC Criteria

May 31, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S 52937

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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