search
Back to results

Study to Determine Pediatric Bladder Volume Prior to Catheterization (PV-BUS)

Primary Purpose

Urinary Tract Infection

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ultrasound prior to bladder catheterization
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infection focused on measuring Urethral catheterization, Emergency Department, Ultrasound, Urinary tract infection, Pediatric

Eligibility Criteria

undefined - 36 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hamilton Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ultrasound

Standard catheterization

Arm Description

Bladder ultrasound prior to catheterization

No ultrasound prior to bladder catheterization

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
February 17, 2009
Last Updated
September 16, 2016
Sponsor
Hamilton Health Sciences Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT00847392
Brief Title
Study to Determine Pediatric Bladder Volume Prior to Catheterization
Acronym
PV-BUS
Official Title
Pediatric Volumetric Bladder Ultrasound Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Inability to obtain grant funding
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
Urethral catheterization, Emergency Department, Ultrasound, Urinary tract infection, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound
Arm Type
Experimental
Arm Description
Bladder ultrasound prior to catheterization
Arm Title
Standard catheterization
Arm Type
No Intervention
Arm Description
No ultrasound prior to bladder catheterization
Intervention Type
Procedure
Intervention Name(s)
Ultrasound prior to bladder catheterization
Intervention Description
Bedside ultrasound to estimated volume of urine in bladder
Primary Outcome Measure Information:
Title
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).

10. Eligibility

Sex
All
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Worster, MD, MSc
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L5G4T8
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Study to Determine Pediatric Bladder Volume Prior to Catheterization

We'll reach out to this number within 24 hrs