Brief Summary

ICU patients are at risk for catheter associated urinary tract infection. Frequently patients can't tell clinicians if they need to void if the catheter is removed. If clinicians know that an accurate volume measurement s of urine volume in the bladder can be obtained when the catheter is removed, catheters could be removed earlier and more frequently and thus possibly avoid an infection. For this study, measures with ultrasound (directly visualizing the bladder to measure), bladder scanner (partially blind measure with placement of scanner over the expected bladder location on the skin) and urine catheterized volume will be obtained. The investigators also want to know if the technology is user dependent. The study will include 2 levels of nurses RN and advanced practice RN (APRN) perform the bladder scanner. An APRN and MD will conduct the ultrasound. Ultrasound is technology primarily used by physicians but APRNs are using the technology technology more frequently. After these 4 measurements, the patient's nurse will perform an intermittent straight catheterization (catheter inserted, urine drained, and catheter removed) as the gold standard comparison.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

11 months study duration

Study Start

First participant enrolled

December 4, 2017

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2018

Completed

18 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed

Last Updated

April 3, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

January 22, 2018

Last Update Submit

April 1, 2019

Conditions

Urinary Retention Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

Intermittent Straight Catheterization Volume Compared to Bladder Scan Measurement Volume
Comparison of the two measurements of bladder volume will be analyzed
At time of enrollment, one point in time
Intermittent Straight Catheterization Volume Compared to Point of Care Ultrasound Measurement Volume
Comparison of the two measurements of bladder volume will be analyzed
At time of enrollment, one point in time

Secondary Outcomes (1)

Clinician Level Measurements with Bladder Scanner and Point of Care Ultrasound
At time of enrollment, one point in time

Study Arms (2)

ICU patient unable to void for 6 hours

ICU patients unable to void after 6 hours after a indwelling urinary catheter is removed or since time of admission

Other: Bladder Volume Measurement bladder scanner RNOther: Bladder Volume Measurement Ultrasound APRNOther: Bladder Volume Measurement bladder scanner APRNOther: Bladder Volume Measurement Ultrasound MDOther: Intermittent Straight Catheterization

renal failure with low urine volume

ICU patients with renal failure, acute kidney injury or acute on chronic with minimal urine output without an indwelling urinary catheter