Measuring Bladder Volumes Scanning in the ICU

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT03428113
Collaborator
(none)
75
1
10.9
6.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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

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 Design

Study Type:
Observational
Actual Enrollment :
75 participants
Observational Model:
Case-Only
Time Perspective:
Other
Official Title:
Measuring Bladder Volumes With Ultrasound and Bladder Scanning in the ICU
Actual Study Start Date :
Dec 4, 2017
Actual Primary Completion Date :
Jul 31, 2018
Actual Study Completion Date :
Nov 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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 RN
Measure Urine Volume with Bladder Scanner by RN
Other Names:
  • Bladder Scanner
  • Other: Bladder Volume Measurement Ultrasound APRN
    Measure Urine Volume with Point of Care Ultrasound by APRN
    Other Names:
  • Ultrasound APRN
  • Other: Bladder Volume Measurement bladder scanner APRN
    Measure Urine Volume with Bladder Scanner by APRN
    Other Names:
  • Bladder Scanner APRN
  • Other: Bladder Volume Measurement Ultrasound MD
    Measure Urine Volume with Point of Care Ultrasound by MD
    Other Names:
  • Ultrasound MD
  • Other: Intermittent Straight Catheterization
    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

    Other: Bladder Volume Measurement bladder scanner RN
    Measure Urine Volume with Bladder Scanner by RN
    Other Names:
  • Bladder Scanner
  • Other: Bladder Volume Measurement Ultrasound APRN
    Measure Urine Volume with Point of Care Ultrasound by APRN
    Other Names:
  • Ultrasound APRN
  • Other: Bladder Volume Measurement bladder scanner APRN
    Measure Urine Volume with Bladder Scanner by APRN
    Other Names:
  • Bladder Scanner APRN
  • Other: Bladder Volume Measurement Ultrasound MD
    Measure Urine Volume with Point of Care Ultrasound by MD
    Other Names:
  • Ultrasound MD
  • Other: Intermittent Straight Catheterization
    Measure Urine Volume with Intermittent Straight Catheterization

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    Secondary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barnes-Jewish Hospital at Washington University Saint Louis Missouri United States 63110

    Sponsors and Collaborators

    • Washington University School of Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lynn Schallom, Director of Research For Patient Care Services at Barnes-Jewish Hospital, Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT03428113
    Other Study ID Numbers:
    • 201704104
    First Posted:
    Feb 9, 2018
    Last Update Posted:
    Apr 3, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 3, 2019