A Randomized Multicenter Clinical Study On the High Vacuum Body Cavity Drainage System Following Open Heart Surgery

NCT00581399 | Completed Phase 2 Results DMC

• 1 other identifier: hs#2006-5196
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Heart Valve Disease

Keywords

Open heart surgery; Cardiopulmonary Bypass; Coronary Artery Bypass Grafting; Chest Tube; Valve Replacement; Valve Repair

Outcome Measures

Primary Outcomes (1)

• Amount of Postoperative Bleeding

  The outcome is to measure the amount of postoperative bleeding in cardiac surgery patients from the time the chest is completely closed until the chest tube is pulled out.

  24-48 hours post surgery

Secondary Outcomes (1)

• Duration of Mediastinal Drainage

  Immediate postoperative when the chest is completely closed to the time chest tubes are pulled out of the patient

Study Arms (2)

NO-NUMO Chest Tube

EXPERIMENTAL

The NO-NUMO™ High Vacuum Body Cavity Drainage System consist of disposable NO-NUMO™ body cavity drainage tubes, disposable Vario™ fluid management canisters Vario™ portable vacuum pump

Device: NO-NUMO™ High Vacuum Body Cavity Drainage System

Standard Chest Tube

ACTIVE COMPARATOR

Classic PVC Chest Tube

Device: PVC Chest Tube

Interventions

NO-NUMO™ High Vacuum Body Cavity Drainage System DEVICE

(1) disposable NO-NUMO™ body cavity drainage tubes, (2) disposable Vario™ fluid management canisters and (3) Vario™ portable vacuum pump

NO-NUMO Chest Tube

PVC Chest Tube DEVICE

Standard PVC Chest Tube Sizes 14-36 French

Standard Chest Tube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr. Jeffrey C. Milliken
• Organization: University of California, Irvine Medical Center

jcmillik@uci.edu

714-456-3634

Study Officials

• Jeffrey C Milliken, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 27, 2007
• Study Start: September 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 31, 2011
• Results First Posted: October 31, 2011

Record last verified: 2011-10

Locations

US (1)