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Completed

NCT Number: NCT03428113

Measuring Bladder Volumes Scanning in the ICU

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.

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Key information

Conditions

Urinary Retention Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Barnes-Jewish Hospital at Washington University

St Louis, Missouri, 63110, United States

About this study

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)

  • MD performs bladder ultrasound and records volume on data collection sheet and places in envelope
  • APRN performs bladder scanner and records volume on data collection sheet and places in envelope.
  • APRN performs bladder ultrasound and records volume on data collection sheet and places in envelope
  • Bedside RN performs bladder scanner and records volume on data collection sheet and places in envelope
  • The study team will record the data from the straight catheterization that is performed as part of clinical care.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bladder Volume Measurement bladder scanner RN

Other

Measure Urine Volume with Bladder Scanner by RN

Other names: Bladder Scanner

Bladder Volume Measurement Ultrasound APRN

Other

Measure Urine Volume with Point of Care Ultrasound by APRN

Other names: Ultrasound APRN

Bladder Volume Measurement bladder scanner APRN

Other

Measure Urine Volume with Bladder Scanner by APRN

Other names: Bladder Scanner APRN

Bladder Volume Measurement Ultrasound MD

Other

Measure Urine Volume with Point of Care Ultrasound by MD

Other names: Ultrasound MD

Intermittent Straight Catheterization

Other

Measure Urine Volume with Intermittent Straight Catheterization

Primary outcomes

  1. Intermittent Straight Catheterization Volume Compared to Bladder Scan Measurement Volume

    Time frame: At time of enrollment, one point in time

    Comparison of the two measurements of bladder volume will be analyzed

  2. Intermittent Straight Catheterization Volume Compared to Point of Care Ultrasound Measurement Volume

    Time frame: At time of enrollment, one point in time

    Comparison of the two measurements of bladder volume will be analyzed

Secondary outcomes

  1. Clinician Level Measurements with Bladder Scanner and Point of Care Ultrasound

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Measuring Bladder Volumes With Ultrasound and Bladder Scanning in the ICU

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 9, 2018
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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