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Measuring Bladder Volumes Scanning in the ICU

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ClinicalTrials.gov Identifier: NCT03428113
Recruitment Status : Enrolling by invitation
First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Lynn Schallom, 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.

Condition or disease Intervention/treatment
Urinary Retention Acute Kidney Injury 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 Type : Observational
Estimated Enrollment : 100 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 : December 4, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort 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 Name: Bladder Scanner

Other: Bladder Volume Measurement Ultrasound APRN
Measure Urine Volume with Point of Care Ultrasound by APRN
Other Name: Ultrasound APRN

Other: Bladder Volume Measurement bladder scanner APRN
Measure Urine Volume with Bladder Scanner by APRN
Other Name: Bladder Scanner APRN

Other: Bladder Volume Measurement Ultrasound MD
Measure Urine Volume with Point of Care Ultrasound by MD
Other Name: 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 Name: Bladder Scanner

Other: Bladder Volume Measurement Ultrasound APRN
Measure Urine Volume with Point of Care Ultrasound by APRN
Other Name: Ultrasound APRN

Other: Bladder Volume Measurement bladder scanner APRN
Measure Urine Volume with Bladder Scanner by APRN
Other Name: Bladder Scanner APRN

Other: Bladder Volume Measurement Ultrasound MD
Measure Urine Volume with Point of Care Ultrasound by MD
Other Name: Ultrasound MD

Other: Intermittent Straight Catheterization
Measure Urine Volume with Intermittent Straight Catheterization




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428113


Locations
United States, Missouri
Barnes-Jewish Hospital at Washington University
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine

Responsible Party: Lynn Schallom, Director of Research For Patient Care Services at Barnes-Jewish Hospital, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03428113     History of Changes
Other Study ID Numbers: 201704104
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Acute Kidney Injury
Urinary Retention
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Urination Disorders