Measuring Bladder Volumes Scanning in the ICU

Acute Kidney Injury Clinical Trial

Official title:

Measuring Bladder Volumes With Ultrasound and Bladder Scanning in the ICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03428113
• Other study ID #: 201704104
• Status: Completed
• Start date: December 4, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: April 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 1, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Urinary Retention

Intervention

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

Locations

Country	Name	City	State
United States	Barnes-Jewish Hospital at Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intermittent Straight Catheterization Volume Compared to Bladder Scan Measurement Volume	Comparison of the two measurements of bladder volume will be analyzed	At time of enrollment, one point in time
Primary	Intermittent Straight Catheterization Volume Compared to Point of Care Ultrasound Measurement Volume	Comparison of the two measurements of bladder volume will be analyzed	At time of enrollment, one point in time
Secondary	Clinician Level Measurements with Bladder Scanner and Point of Care Ultrasound	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	At time of enrollment, one point in time