Cardiovascular Surgical ProcedureNCT01296685
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 of Cardiovascular Surgical Procedure, run by Universitaire Ziekenhuizen KU Leuven.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Surgical Procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to not given
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- All children with body surface area between 0.25 and 0.5 m² who need cardiac surgery with cardiopulmonary bypass.
Who cannot join
- Urgent and norwood procedures.
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| oxygenator with arterial filter | Not described | |
| arterial filter | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Surgical ProcedureStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Investigators
- Layth Al Tmimi, Dr., Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296685
- Sponsor's protocol ID
- S 52937
- Status last verified
- Feb 2011
- First submitted
- 14 Feb 2011
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes