- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00847392
Study to Determine Pediatric Bladder Volume Prior to Catheterization (PV-BUS)
Pediatric Volumetric Bladder Ultrasound Study
This is a randomized controlled trial evaluating the effectiveness of bedside volumetric bladder ultrasound prior to transurethral catheterization of pediatric patients presenting to an emergency department with suspected urinary tract infection.
Ultrasound prior to catheterization allows Emergency Physicians to determine if the urine volume of the bladder is sufficient for successful catheterization. Advance knowledge of insufficient urine allows the Emergency Physician to defer the procedure until success is likely.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L5G4T8
- Hamilton Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children 0-36 months of age
- Require urethral catheterization for urine analysis
Exclusion Criteria:
- Recently voided and unlikely to provide sufficient urine when catheterized
- Documented or suspected genitourinary abnormalities precluding urethral catheterization
- Indwelling catheter or urostomy
- Critical illness
- No available legal guardian or legal guardian does not understand English well enough to provide informed consent
- Technical failure of the utlrasound equipment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ultrasound
Bladder ultrasound prior to catheterization
|
Bedside ultrasound to estimated volume of urine in bladder
|
No Intervention: Standard catheterization
No ultrasound prior to bladder catheterization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The proportion of patients in each arm from whom at least 2 ml of urine is obtained on first attempt at catheterization.
Time Frame: First feasible attempt at catheterization during ED visit (minutes-hours).
|
First feasible attempt at catheterization during ED visit (minutes-hours).
|
Collaborators and Investigators
Investigators
- Principal Investigator: Andrew Worster, MD, MSc, Hamilton Health Sciences Corporation
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PV-BUS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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