Emergency Department Targeted Ultrasound for the Detection of Hydronephrosis

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00555308
First received: November 7, 2007
Last updated: July 21, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention
Urolithiasis
Ultrasonography
Hydronephrosis
Other: emergency department targeted ultrasound imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Emergency Department Targeted Ultrasound for the Detection of Hydronephrosis

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Diagnostic accuracy of EDTU [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • same measures of diagnostic accuracy in the planned subgroup of patients being investigated for suspected renal colic [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: November 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: one
undergo EDTU
Other: emergency department targeted ultrasound imaging
bedside ultrasound performed by emergency physician to identify hydronephrosis
Other Name: EDTU

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555308

Locations
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Eric A Bruder, MD Queen's University
Study Director: Kieran M Moore, MD MMSc Queen's University
Study Director: Louise Rang, MD RDMS Queen's University
  More Information

No publications provided

Responsible Party: Dr. Kieran Moore, Queen's University
ClinicalTrials.gov Identifier: NCT00555308     History of Changes
Other Study ID Numbers: EMED 094-07, PSI Grant Sept 2007
Study First Received: November 7, 2007
Last Updated: July 21, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen's University:
urolithiasis
ultrasound
hydronephrosis

Additional relevant MeSH terms:
Emergencies
Hydronephrosis
Urolithiasis
Disease Attributes
Pathologic Processes
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014