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

NCT ID: NCT02052674

Last Updated: 2019-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bacteriuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Vented urinary drainage system

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

Non-vented urinary drainage system

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Covidien vented foley catheter TopVent Covidien Dover Precision Premium Drainage bag Bard urine drainage system Conventional catheter Bard Silver-Coated

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William B. Smith, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Other Identifiers

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201300634

Identifier Type: -

Identifier Source: org_study_id

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