Clinical trial NCT03428113: Measuring Bladder Volumes Scanning in the ICU
Official title: Measuring Bladder Volumes With Ultrasound and Bladder Scanning in the ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Retention
Acute Kidney Injury
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients with low urine output due to new acute kidney injury or patients unable to void, secondary to surgical procedure, change in level of consciousness, or neurological alteration

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intermittent Straight Catheterization Volume Compared to Bladder Scan Measurement Volume
timeFrame: At time of enrollment, one point in time
measure: Intermittent Straight Catheterization Volume Compared to Point of Care Ultrasound Measurement Volume
timeFrame: At time of enrollment, one point in time
Secondary outcomes:
measure: Clinician Level Measurements with Bladder Scanner and Point of Care Ultrasound
timeFrame: At time of enrollment, one point in time
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital at Washington University
state: Missouri
Study officials:
References: