A Randomized Multicenter Clinical Study On the High Vacuum Body Cavity Drainage System Following Open Heart Surgery
Completed · Phase 2
Conditions studied: Coronary Artery Disease, Heart Valve Disease
In brief
The purpose of this study is to compare a new high vacuum pressure chest drainage system (NO-NUMO™) with the standard low vacuum pressure drainage system already in use in cardiac surgeries. The new system uses smaller diameter drainage tubing to remove blood from the chest after open heart surgery. This is less painful to the patient and should help the patient to breathe better after operation. Preliminary data suggests that the high vacuum suction is effective and practical, and could actually reduce the amount of chest tube bleeding after surgery without compromising heart function. This new high vacuum drainage system was approved by the FDA in 2002. Subsequent testing at University of California, Irvine indicated that this unique system may allow the surgeon to predict excessive postoperative bleeding before the patient is transferred out of the operating room, thus adding safety, convenience, and cost effectiveness to their use.
Key facts
- Study ID
- NCT00581399
- Run by
- University of California, Irvine
- People needed
- 94
- Starts
- 2006-09-01
- Expected to finish
- 2010-09-01
- Last updated by the study team
- 2011-10-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or Female 18 year-old or older
- Patients undergoing open heart surgery by means of a standard cardiopulmonary bypass
- The surgical procedures accepted include:
- Coronary-artery-bypass grafting
- Valve replacement or repair, or a combination of both
- Excision of a left ventricular aneurysm
- Bentall procedure is included but we do not include those undergoing replacement of the aortic arch aneurysm, utilizing deep hypothermic circulatory arrest.
- We include both first time operation and re-do operations.
- Patients with insulin dependent diabetes mellitus are included. Those with chronic renal failure who are on a hemodialysis treatment will be included.
- Emergency CABG for unstable angina following acute myocardial infarction
- Patients must agreed to participate and sign an Informed Consent Form before the surgical procedure
You may not qualify if…
- Transmyocardial laser revascularization
- Open heart surgery for congenital heart diseases.
Where it is running
- University of California, Irvine Medical Center — Orange, California, United States
Full record on ClinicalTrials.gov
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