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

Phase 1WithdrawnNCT02052674

University of Florida

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Bacteriuria

Interventions

Vented urinary drainage systemDEVICE

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 systemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bacteriuria

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.

Time frame: 7 days

Secondary Outcomes

Retained Urine

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

Time frame: 7 days

Presence of biofilms in catheter materials

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

Time frame: 7 days

Data from ClinicalTrials.gov

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