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Retained Urine Volume and Bacteriuria in Traditional Versus Vented Urine Drainage Systems

Sponsor
University of Florida (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02052674
Collaborator
(none)
0
Enrollment
2
Arms
1
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to see if there are differences in urine drainage between two types of indwelling bladder catheter systems (Foley catheter) in hospitalized patients. The difference between the two catheters is that one catheter is vented (the study catheter) and the other is a standard non-vented catheter. The vented catheter may drain urine better than a standard non-vented catheter.

If a vented catheter drains the bladder better than a non-vented catheter it may lower the risk of retained urine in the bladder which could help prevent urinary tract infections.

Condition or Disease Intervention/Treatment Phase
  • Device: Vented urinary drainage system
  • Device: Non-vented urinary drainage system
 Phase 1

Detailed Description

During hospitalization, while in the surgical intensive care unit beginning the day after surgery, measurements of the subject's urine drainage system will be taken at daily study visits: retained urine volume, dependent loops, incidence of bacteriuria, and thigh diameter.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Retained Urine Volume and Bacteriuria in Traditional Versus Vented Urine Drainage Systems
Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Apr 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vented urinary drainage system

This group will be catheterized with a vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.

Device: Vented urinary drainage system
This group will be catheterized with a vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.
Other Names:
  • Covidien vented foley catheter
  • TopVent
  • Covidien Dover Precision Premium Drainage bag

    		•
    Active Comparator: Non-vented urinary drainage system

    This group will be catheterized with a non-vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.

    Device: Non-vented urinary drainage system
    This group will be catheterized with a non-vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.
    Other Names:
  • Bard urine drainage system
  • Conventional catheter
  • Bard Silver-Coated

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bacteriuria [7 days]

      Evidence of bacteriuria, a potential precursor to Catheter Associated Urinary Tract Infection (CAUTI), will be used to study the potential effect of the vented urinary drainage system intervention on CAUTI.

    Secondary Outcome Measures

    1. Retained Urine [7 days]

      One potential source for the risk of developing a Urinary Tract Infection (UTI) is related to residual urine volume in the bladder

    2. Presence of biofilms in catheter materials [7 days]

      A key contributor to bacteriuria is formation of biofilms in the catheter and catheter tubing.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Scheduled for a planned surgery

    • Anticipated indwelling bladder catheter placement for greater than 24 hours

    • Anticipated post-op admission to a surgical ICU

    Exclusion Criteria:

    • Unstable renal function as self-reported

    • Anticipated bandaged postoperative suprapubic incisions

    • Anatomical deformity that precludes appropriate suprapubic access for ultrasound bladder scanning

    • Surgical procedure that prevents accurate core body temperature by any means other than by bladder temperature

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Florida

    Investigators

    • Principal Investigator: William B. Smith, MD, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT02052674
    Other Study ID Numbers:
    • 201300634
    First Posted:
    Feb 3, 2014
    Last Update Posted:
    Jul 24, 2019
    Last Verified:
    Jul 1, 2019
    Keywords provided by University of Florida
    Precursor to CAUTI
    Additional relevant MeSH terms:
    Bacteriuria

    Study Results

    No Results Posted as of Jul 24, 2019