Measuring Bladder Volumes Scanning in the ICU

Completed

• Conditions: Acute Kidney Injury; Urinary Retention
• Interventions: Other: Bladder Volume Measurement bladder scanner RN; Other: Bladder Volume Measurement Ultrasound APRN; Other: Bladder Volume Measurement bladder scanner APRN; Other: Bladder Volume Measurement Ultrasound MD; Other: Intermittent Straight Catheterization

• Registration Number: NCT03428113
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

The purpose of this correlational descriptive study is to compare measured bladder volumes with a bladder scanner (Verathon Prime), 3D ultrasound (Sono-Site II) and straight catheterization in ICU patients with low urine output receiving dialysis and in ICU patients unable to void.

Upon consent of patient or LAR, patient's age, gender and BMI with the assigned study code number will be recorded on enrollment log. Study code number, patient initials and unit will be written on bedside data collection sheet.

Sequence of 4 non-invasive (1-4) measurement will vary from day to day (see below)

1. MD performs bladder ultrasound and records volume on data collection sheet and places in envelope

2. APRN performs bladder scanner and records volume on data collection sheet and places in envelope.

3. APRN performs bladder ultrasound and records volume on data collection sheet and places in envelope

4. Bedside RN performs bladder scanner and records volume on data collection sheet and places in envelope

5. The study team will record the data from the straight catheterization that is performed as part of clinical care.

6. APRN or research nurse will retrieve catheterization urine volume measurement from RN or from chart and record on data collection sheet

Each enrolled patient will have these 4 measurements performed only on one day. Each clinician research team member will record their result on a data collection form with the study number, patient initials, day of week, clinician initials, observation of abdominal fluid, and comment section for any other observations. The clinician research team member will place the completed form for their measurement in an envelope with the study number on the outside while the next clinician is in the room obtaining the next measure.

Data collection is complete after catheter volume is recorded.

Study Timeline

• Study Start: 2017-12-04
• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-02-03
• Study First Posted: 2018-02-09
• Primary Completion: 2018-07-31
• Study Completion: 2018-11-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• ICU dialysis patients who have their catheter removed per ICU medical team
• ICU patients without an indwelling urinary catheter and inability to void 6 hours post urinary catheter removal or 6 hours after admission

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Exclusion Criteria

• Pregnant women Prisoners

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU patient unable to void for 6 hours	Bladder Volume Measurement bladder scanner RN	ICU patients unable to void after 6 hours after a indwelling urinary catheter is removed or since time of admission
ICU patient unable to void for 6 hours	Bladder Volume Measurement Ultrasound MD	ICU patients unable to void after 6 hours after a indwelling urinary catheter is removed or since time of admission
renal failure with low urine volume	Bladder Volume Measurement bladder scanner RN	ICU patients with renal failure, acute kidney injury or acute on chronic with minimal urine output without an indwelling urinary catheter
ICU patient unable to void for 6 hours	Bladder Volume Measurement Ultrasound APRN	ICU patients unable to void after 6 hours after a indwelling urinary catheter is removed or since time of admission
ICU patient unable to void for 6 hours	Bladder Volume Measurement bladder scanner APRN	ICU patients unable to void after 6 hours after a indwelling urinary catheter is removed or since time of admission
renal failure with low urine volume	Bladder Volume Measurement bladder scanner APRN	ICU patients with renal failure, acute kidney injury or acute on chronic with minimal urine output without an indwelling urinary catheter
renal failure with low urine volume	Bladder Volume Measurement Ultrasound MD	ICU patients with renal failure, acute kidney injury or acute on chronic with minimal urine output without an indwelling urinary catheter
renal failure with low urine volume	Intermittent Straight Catheterization	ICU patients with renal failure, acute kidney injury or acute on chronic with minimal urine output without an indwelling urinary catheter
ICU patient unable to void for 6 hours	Intermittent Straight Catheterization	ICU patients unable to void after 6 hours after a indwelling urinary catheter is removed or since time of admission
renal failure with low urine volume	Bladder Volume Measurement Ultrasound APRN	ICU patients with renal failure, acute kidney injury or acute on chronic with minimal urine output without an indwelling urinary catheter

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Clinician Level Measurements with Bladder Scanner and Point of Care Ultrasound	At time of enrollment, one point in time	Comparison of the two measurements between clinicians 1. Bladder Scan measurement by bedside RN compared to APRN bladder scan measurement) and 2. APRN Ultrasound compared to MD US will be analyzed

Trial Locations

Locations (1)

Barnes-Jewish Hospital at Washington University; 🇺🇸 Saint Louis, Missouri, United States