Emergency Department Targeted Ultrasound for the Detection of Hydronephrosis

Ultrasonography Clinical Trial

Official title:

Emergency Department Targeted Ultrasound for the Detection of Hydronephrosis

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

• Hydronephrosis
• Ultrasonography
• Urolithiasis

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