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

NCT00581399 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2011-10-31

Study results available
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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

Interventions

DEVICE

NO-NUMO™ High Vacuum Body Cavity Drainage System

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

DEVICE

PVC Chest Tube

Standard PVC Chest Tube Sizes 14-36 French

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Jeffrey C Milliken, MD · University of California, Irvine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2010-07-31
Completion
2010-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00581399 on ClinicalTrials.gov