Phase 2
N=94
A Randomized Multicenter Clinical Study On the High Vacuum Body Cavity Drainage System Following Open Heart Surgery
Coronary Artery Disease · Heart Valve Disease
Bottom Line
View on ClinicalTrials.gov: NCT00581399 ↗Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcome: Primary: Amount of Postoperative Bleeding — 868.9; 1467.6 mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NO-NUMO™ High Vacuum Body Cavity Drainage System (Device); PVC Chest Tube (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Irvine
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amount of Postoperative Bleeding |
868.9; 1467.6 | — |
| SECONDARY Duration of Mediastinal Drainage |
44.57; 54.74 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Transmyocardial laser revascularization
- Open heart surgery for congenital heart diseases.
Data sourced from ClinicalTrials.gov (NCT00581399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.