CClinicalTrials.gg
Status unknownNCT01296685Updated Jun 1, 2011

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

An observational study in Cardiovascular Surgical Procedure, sponsored by Universitaire Ziekenhuizen KU Leuven. Status unknown. Per ClinicalTrials.gov, last updated 2011-06-01.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

The sponsor has not verified this record recently (last verified Feb 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Sex
All
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Study 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.

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Conditions studied

  • Cardiovascular Surgical Procedure

Keywords

  • cardiovascular surgical procedure
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In context

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Urgent and norwood procedures.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (estimated)

Groups and cohorts

  • oxygenator with arterial filter
  • arterial filter
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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01296685
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
First posted
Feb 15, 2011
Start date
Mar 2011
Last update
Jun 1, 2011

Study contacts

Layth Al Tmimi, Dr.
principal investigator · Universitaire Ziekenhuizen KU Leuven

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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