A Randomized Multicenter Clinical Study On the High Vacuum Body Cavity Drainage System Following Open Heart Surgery
Condition: Coronary Artery Disease; Heart Valve Disease
MeSH terms: Coronary Artery Disease; Heart Valve Diseases
Intervention: NO-NUMO™ High Vacuum Body Cavity Drainage System; PVC Chest Tube
Intervention description: (1) disposable NO-NUMO™ body cavity drainage tubes, (2) disposable Vario™ fluid management canisters and (3) Vario™ portable vacuum pump; Standard PVC Chest Tube Sizes 14-36 French
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open heart surgery; Cardiopulmonary Bypass; Coronary Artery Bypass Grafting; Chest Tube; Valve Replacement; Valve Repair

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:

          1. Male or Female 18 year-old or older

          2. Patients undergoing open heart surgery by means of a standard cardiopulmonary bypass

          3. The surgical procedures accepted include:

               1. Coronary-artery-bypass grafting

               2. Valve replacement or repair, or a combination of both

               3. Excision of a left ventricular aneurysm

               4. Bentall procedure is included but we do not include those undergoing replacement
                  of the aortic arch aneurysm, utilizing deep hypothermic circulatory arrest.

               5. We include both first time operation and re-do operations.

               6. Patients with insulin dependent diabetes mellitus are included. Those with
                  chronic renal failure who are on a hemodialysis treatment will be included.

               7. Emergency CABG for unstable angina following acute myocardial infarction

          4. Patients must agreed to participate and sign an Informed Consent Form before the
             surgical procedure

        Exclusion Criteria:

          1. Transmyocardial laser revascularization

          2. Open heart surgery for congenital heart diseases.