Study to Determine Pediatric Bladder Volume Prior to Catheterization

Urinary Tract Infection Clinical Trial

— PV-BUS  

Official title:

Pediatric Volumetric Bladder Ultrasound Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00847392
• Other study ID #: PV-BUS
• Status: Withdrawn
• Phase: N/A
• First received: February 17, 2009
• Last updated: September 16, 2016
• Start date: March 2009
• Est. completion date: June 2009

Study information

• Verified date: September 2016
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 36 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Procedure:
• Ultrasound prior to bladder catheterization
Bedside ultrasound to estimated volume of urine in bladder

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients in each arm from whom at least 2 ml of urine is obtained on first attempt at catheterization.		First feasible attempt at catheterization during ED visit (minutes-hours).	No