A Randomized Multicenter Clinical Study On the High Vacuum Body Cavity Drainage System Following Open Heart Surgery (NO-NUMO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00581399
First received: December 20, 2007
Last updated: October 27, 2011
Last verified: October 2011
Results First Received: April 25, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Coronary Artery Disease
Heart Valve Disease
Interventions: Device: NO-NUMO™ High Vacuum Body Cavity Drainage System
Device: PVC Chest Tube

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects admitted to UCI Medical Center and scheduled for cardiac surgery (Coronary Artery Bypass Graft [CABG] with or without Heart valve repair, Heart valve repair alone without CABG) were randomized to one of two study arms: High Vacuum Chest Tubes or Standard of Care Chest Tubes. The enrollment period was from July 2006 through May 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Only subjects that met specific study inclusion/exclusion criteria were enrolled into the study.

Reporting Groups
  Description
No-NumoChest Tubes High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
Standard of Care Chest Tubes Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.

Participant Flow:   Overall Study
    No-NumoChest Tubes     Standard of Care Chest Tubes  
STARTED     46     48  
COMPLETED     46     48  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
No-NumoChest Tubes High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
Standard of Care Chest Tubes Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
Total Total of all reporting groups

Baseline Measures
    No-NumoChest Tubes     Standard of Care Chest Tubes     Total  
Number of Participants  
[units: participants]
  46     48     94  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     31     31     62  
>=65 years     15     17     32  
Gender  
[units: participants]
     
Female     10     14     24  
Male     36     34     70  
Region of Enrollment  
[units: participants]
     
United States     46     48     94  



  Outcome Measures
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1.  Primary:   Amount of Postoperative Bleeding   [ Time Frame: 24-48 hours post surgery ]

2.  Secondary:   Duration of Mediastinal Drainage   [ Time Frame: Immediate postoperative when the chest is completely closed to the time chest tubes are pulled out of the patient ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Jeffrey C. Milliken
Organization: University of California, Irvine Medical Center
phone: 714-456-3634
e-mail: jcmillik@uci.edu


No publications provided


Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00581399     History of Changes
Other Study ID Numbers: hs#2006-5196
Study First Received: December 20, 2007
Results First Received: April 25, 2011
Last Updated: October 27, 2011
Health Authority: United States: Institutional Review Board