Measuring Bladder Volumes Scanning in the ICU

• ClinicalTrials.gov Identifier: NCT03428113
• Recruitment Status: Completed
• First Posted: February 9, 2018
• Last Update Posted: April 3, 2019
• Sponsor: Washington University School of Medicine
• Information provided by (Responsible Party): Lynn Schallom, Washington University School of Medicine

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
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 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: December 4, 2017
• Actual Primary Completion Date: July 31, 2018
• Actual Study Completion Date: November 1, 2018

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Missouri

Barnes-Jewish Hospital at Washington University

Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

More Information

• 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: February 9, 2018
• Last Update Posted: April 3, 2019
• Last Verified: April 2019

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