Study to Determine Pediatric Bladder Volume Prior to Catheterization

NCT ID: NCT00847392

Last Updated: 2016-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-06-30

Brief Summary

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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

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Conditions

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Urinary Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultrasound

Bladder ultrasound prior to catheterization

Group Type EXPERIMENTAL

Ultrasound prior to bladder catheterization

Intervention Type PROCEDURE

Bedside ultrasound to estimated volume of urine in bladder

Standard catheterization

No ultrasound prior to bladder catheterization

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ultrasound prior to bladder catheterization

Bedside ultrasound to estimated volume of urine in bladder

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Responsible Party

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Hamilton Health Sciences

Principal Investigators

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Andrew Worster, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Corporation

Locations

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Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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PV-BUS

Identifier Type: -

Identifier Source: org_study_id

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