Study to Determine Pediatric Bladder Volume Prior to Catheterization

NCT00847392 | Withdrawn

• 1 other identifier: PV-BUS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infection

Keywords

Urethral catheterization; Emergency Department; Ultrasound; Urinary tract infection; Pediatric

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (2)

Ultrasound

EXPERIMENTAL

Bladder ultrasound prior to catheterization

Procedure: Ultrasound prior to bladder catheterization

Standard catheterization

NO INTERVENTION

No ultrasound prior to bladder catheterization

Interventions

Ultrasound prior to bladder catheterization PROCEDURE

Bedside ultrasound to estimated volume of urine in bladder

Ultrasound

Eligibility Criteria

• Age: Up to 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 0-36 months of age
• Require urethral catheterization for urine analysis

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L5G4T8, Canada

Location

MeSH Terms

Conditions

Urinary Tract Infections; Emergencies

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Worster, MD, MSc

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 19, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 19, 2016

Record last verified: 2016-09

Locations

CA (1)