NCT00555308

Brief Summary

An Emergency Department Targeted Ultrasound (EDTU) is an ultrasound examination performed by an emergency department physician, instead of a radiologist or ultrasound technician. EDTU is intended to be a readily assessable test performed at the bedside, to quickly and safely determine the presence of a disease state; it answers a binary question, as compared to formal ultrasound imaging which seeks to determine the cause of a patient's symptoms. The objective of this study is to determine the accuracy of EDTU in patients suspected of renal colic. By demonstrating excellent test characteristics, these investigators hope that this research will be used to incorporate EDTU for hydronephrosis into standard emergency care in Canada.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

July 22, 2009

Status Verified

July 1, 2009

Enrollment Period

1.6 years

First QC Date

November 7, 2007

Last Update Submit

July 21, 2009

Conditions

UrolithiasisUltrasonographyHydronephrosis

Keywords

urolithiasisultrasoundhydronephrosis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of EDTU

    1 hour

Secondary Outcomes (1)

  • same measures of diagnostic accuracy in the planned subgroup of patients being investigated for suspected renal colic

    1 hour

Study Arms (1)

one

EXPERIMENTAL

undergo EDTU

Other: emergency department targeted ultrasound imaging

Interventions

emergency department targeted ultrasound imagingOTHER

bedside ultrasound performed by emergency physician to identify hydronephrosis

Also known as: EDTU
one

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Emergency Department patients
  • Males and Females
  • Age 16-65
  • Undergoing CT scan of the abdomen or formal ultrasound of the abdomen at Kingston General Hospital or Hotel Dieu Hospital in Kingston, Ontario.

You may not qualify if:

  • Hemodynamic instability
  • Fever
  • Leukocytes or nitrites on dipstick urinalysis
  • Pregnancy
  • Renal failure
  • Single functioning kidney or renal transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hotel Dieu Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

UrolithiasisHydronephrosis

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesKidney Diseases

Study Officials

  • Eric A Bruder, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

  • Kieran M Moore, MD MMSc

    Queen's University

    STUDY DIRECTOR

  • Louise Rang, MD RDMS

    Queen's University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2007

First Posted

November 8, 2007

Study Start

November 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

July 22, 2009

Record last verified: 2009-07

Locations

CA(2)