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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00555308
Other study ID # EMED 094-07
Secondary ID PSI Grant Sept 2
Status Completed
Phase N/A
First received November 7, 2007
Last updated July 21, 2009
Start date November 2007
Est. completion date June 2009

Study information

Verified date July 2009
Source Queen's University
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 65 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Hemodynamic instability

- Fever

- Leukocytes or nitrites on dipstick urinalysis

- Pregnancy

- Renal failure

- Single functioning kidney or renal transplant

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
emergency department targeted ultrasound imaging
bedside ultrasound performed by emergency physician to identify hydronephrosis

Locations

Country Name City State
Canada Hotel Dieu Hospital Kingston Ontario
Canada Kingston General Hospital Kingston Ontario

Sponsors (2)

Lead Sponsor Collaborator
Queen's University The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy of EDTU 1 hour No
Secondary same measures of diagnostic accuracy in the planned subgroup of patients being investigated for suspected renal colic 1 hour No
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