Measuring Bladder Volumes Scanning in the ICU

NCT ID: NCT03428113

Last Updated: 2019-04-03

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

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-04

Study Completion Date

2018-11-01

Brief Summary

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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

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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.

Conditions

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Urinary Retention Acute Kidney Injury

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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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

Bladder Volume Measurement bladder scanner RN

Intervention Type OTHER

Measure Urine Volume with Bladder Scanner by RN

Bladder Volume Measurement Ultrasound APRN

Intervention Type OTHER

Measure Urine Volume with Point of Care Ultrasound by APRN

Bladder Volume Measurement bladder scanner APRN

Intervention Type OTHER

Measure Urine Volume with Bladder Scanner by APRN

Bladder Volume Measurement Ultrasound MD

Intervention Type OTHER

Measure Urine Volume with Point of Care Ultrasound by MD

Intermittent Straight Catheterization

Intervention Type OTHER

Measure Urine Volume with 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

Bladder Volume Measurement bladder scanner RN

Intervention Type OTHER

Measure Urine Volume with Bladder Scanner by RN

Bladder Volume Measurement Ultrasound APRN

Intervention Type OTHER

Measure Urine Volume with Point of Care Ultrasound by APRN

Bladder Volume Measurement bladder scanner APRN

Intervention Type OTHER

Measure Urine Volume with Bladder Scanner by APRN

Bladder Volume Measurement Ultrasound MD

Intervention Type OTHER

Measure Urine Volume with Point of Care Ultrasound by MD

Intermittent Straight Catheterization

Intervention Type OTHER

Measure Urine Volume with Intermittent Straight Catheterization

Interventions

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Bladder Volume Measurement bladder scanner RN

Measure Urine Volume with Bladder Scanner by RN

Intervention Type OTHER

Bladder Volume Measurement Ultrasound APRN

Measure Urine Volume with Point of Care Ultrasound by APRN

Intervention Type OTHER

Bladder Volume Measurement bladder scanner APRN

Measure Urine Volume with Bladder Scanner by APRN

Intervention Type OTHER

Bladder Volume Measurement Ultrasound MD

Measure Urine Volume with Point of Care Ultrasound by MD

Intervention Type OTHER

Intermittent Straight Catheterization

Measure Urine Volume with Intermittent Straight Catheterization

Intervention Type OTHER

Other Intervention Names

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Bladder Scanner Ultrasound APRN Bladder Scanner APRN Ultrasound MD

Eligibility Criteria

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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

Exclusion Criteria

* Pregnant women Prisoners
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Lynn Schallom

Director of Research For Patient Care Services at Barnes-Jewish Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Barnes-Jewish Hospital at Washington University

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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201704104

Identifier Type: -

Identifier Source: org_study_id

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