Study to Determine Pediatric Bladder Volume Prior to Catheterization

Not Applicable

Withdrawn

• Conditions: Urinary Tract Infection
• Interventions: Procedure: Ultrasound prior to bladder catheterization

• Registration Number: NCT00847392
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-19
• Study Start: 2009-03
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-16
• Last Update Posted: 2016-09-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound	Ultrasound prior to bladder catheterization	Bladder ultrasound prior to catheterization

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada