Urinary RetentionNCT03428113
Measuring Bladder Volumes Scanning in the ICU
An observational study of Urinary Retention and Acute Kidney Injury, run by Washington University School of Medicine at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Urinary Retention, Acute Kidney Injury
- What is being tested?
- Bladder Volume Measurement bladder scanner RN, Bladder Volume Measurement Ultrasound APRN and Bladder Volume Measurement bladder scanner APRN
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2017to 1 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Pregnant women Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Barnes-Jewish Hospital at Washington University
St Louis, Missouri, 63110
About this study
Official title: Measuring Bladder Volumes With Ultrasound and Bladder 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.
Read the 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)
- 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.
- Conditions
- Urinary Retention, Acute Kidney Injury
- Being tested
- Bladder Volume Measurement bladder scanner RN, Bladder Volume Measurement Ultrasound APRN, Bladder Volume Measurement bladder scanner APRN, Bladder Volume Measurement Ultrasound MD, Intermittent Straight Catheterization
- Medical subject headings
- Urinary Retention, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder Volume Measurement bladder scanner RNOther
Also called Bladder Scanner
Measure Urine Volume with Bladder Scanner by RN
Bladder Volume Measurement Ultrasound APRNOther
Also called Ultrasound APRN
Measure Urine Volume with Point of Care Ultrasound by APRN
Bladder Volume Measurement bladder scanner APRNOther
Also called Bladder Scanner APRN
Measure Urine Volume with Bladder Scanner by APRN
Bladder Volume Measurement Ultrasound MDOther
Also called Ultrasound MD
Measure Urine Volume with Point of Care Ultrasound by MD
Intermittent Straight CatheterizationOther
Measure Urine Volume with Intermittent Straight Catheterization
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 | |
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intermittent Straight Catheterization Volume Compared to Bladder Scan Measurement Volume
Comparison of the two measurements of bladder volume will be analyzed
Measured: At time of enrollment, one point in time
Intermittent Straight Catheterization Volume Compared to Point of Care Ultrasound Measurement Volume
Comparison of the two measurements of bladder volume will be analyzed
Measured: At time of enrollment, one point in time
Secondary outcomes (1)
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
Measured: At time of enrollment, one point in time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start4 Dec 2017
- Primary completion31 Jul 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynn Schallom, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428113
- Sponsor's protocol ID
- 201704104
- Status last verified
- Apr 2019
- First submitted
- 22 Jan 2018
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Bladder Volumes With Ultrasound and Bladder Scanning in the ICU
- ClinicalTrials.gov ID
- NCT03428113
- Acronym / sponsor ID
- 201704104
- Conditions
- Urinary Retention, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU patient unable to void for 6 hours | – | 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 CatheterizationICU patients unable to void after 6 hours after a indwelling urinary catheter is removed or since time of admission |
| renal failure with low urine volume | – | 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 CatheterizationICU patients with renal failure, acute kidney injury or acute on chronic with minimal urine output without an indwelling urinary catheter |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant women Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bladder Volume Measurement bladder scanner RNAlso: Bladder ScannerMeasure Urine Volume with Bladder Scanner by RN | Other | ICU patient unable to void for 6 hours, renal failure with low urine volume |
| Bladder Volume Measurement Ultrasound APRNAlso: Ultrasound APRNMeasure Urine Volume with Point of Care Ultrasound by APRN | Other | ICU patient unable to void for 6 hours, renal failure with low urine volume |
| Bladder Volume Measurement bladder scanner APRNAlso: Bladder Scanner APRNMeasure Urine Volume with Bladder Scanner by APRN | Other | ICU patient unable to void for 6 hours, renal failure with low urine volume |
| Bladder Volume Measurement Ultrasound MDAlso: Ultrasound MDMeasure Urine Volume with Point of Care Ultrasound by MD | Other | ICU patient unable to void for 6 hours, renal failure with low urine volume |
| Intermittent Straight CatheterizationMeasure Urine Volume with Intermittent Straight Catheterization | Other | ICU patient unable to void for 6 hours, renal failure with low urine volume |
Primary outcome
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
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
1 secondary outcome
Clinician Level Measurements with Bladder Scanner and Point of Care Ultrasound
Time frame: At time of enrollment, one point in time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Retention and Acute Kidney Injury, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intermittent Straight Catheterization Volume Compared to Bladder Scan Measurement Volume (time frame: At time of enrollment, one point in time). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.