Study to Determine Pediatric Bladder Volume Prior to Catheterization (PV-BUS)
This study has been withdrawn prior to enrollment.
(Inability to obtain grant funding)
Sponsor:
Hamilton Health Sciences Corporation
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00847392
First received: February 17, 2009
Last updated: June 24, 2009
Last verified: June 2009
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Purpose
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.
Condition | Intervention |
---|---|
Urinary Tract Infection |
Procedure: Ultrasound prior to bladder catheterization |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Pediatric Volumetric Bladder Ultrasound Study |
Resource links provided by NLM:
Further study details as provided by McMaster University:
Primary Outcome Measures:
- 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). ] [ Designated as safety issue: No ]
Estimated Enrollment: | 120 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Ultrasound
Bladder ultrasound prior to catheterization
|
Procedure: Ultrasound prior to bladder catheterization
Bedside ultrasound to estimated volume of urine in bladder
|
No Intervention: Standard catheterization
No ultrasound prior to bladder catheterization
|
Eligibility
Ages Eligible for Study: | up to 36 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847392
Locations
Canada, Ontario | |
Hamilton Health Sciences | |
Hamilton, Ontario, Canada, L5G4T8 |
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: | Andrew Worster, MD, MSc | Hamilton Health Sciences Corporation |
More Information
No publications provided
Keywords provided by McMaster University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 26, 2012
No publications provided
Responsible Party: | Dr. Andrew Worster, Hamilton Health Sciences |
ClinicalTrials.gov Identifier: | NCT00847392 History of Changes |
Other Study ID Numbers: | PV-BUS |
Study First Received: | February 17, 2009 |
Last Updated: | June 24, 2009 |
Health Authority: | Canada: Canadian Institutes of Health Research |
Keywords provided by McMaster University:
Urethral catheterization Emergency Department Ultrasound Urinary tract infection Pediatric |
Additional relevant MeSH terms:
Urinary Tract Infections Infection Urologic Diseases |
ClinicalTrials.gov processed this record on September 26, 2012