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Emergency Department Targeted Ultrasound for the Detection of Hydronephrosis

Primary Purpose

Urolithiasis, Ultrasonography, Hydronephrosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
emergency department targeted ultrasound imaging
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urolithiasis focused on measuring urolithiasis, ultrasound, hydronephrosis

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hotel Dieu Hospital
  • Kingston General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

one

Arm Description

undergo EDTU

Outcomes

Primary Outcome Measures

Diagnostic accuracy of EDTU

Secondary Outcome Measures

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

Full Information

First Posted
November 7, 2007
Last Updated
July 21, 2009
Sponsor
Queen's University
Collaborators
The Physicians' Services Incorporated Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00555308
Brief Title
Emergency Department Targeted Ultrasound for the Detection of Hydronephrosis
Official Title
Emergency Department Targeted Ultrasound for the Detection of Hydronephrosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Queen's University
Collaborators
The Physicians' Services Incorporated Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis, Ultrasonography, Hydronephrosis
Keywords
urolithiasis, ultrasound, hydronephrosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
one
Arm Type
Experimental
Arm Description
undergo EDTU
Intervention Type
Other
Intervention Name(s)
emergency department targeted ultrasound imaging
Other Intervention Name(s)
EDTU
Intervention Description
bedside ultrasound performed by emergency physician to identify hydronephrosis
Primary Outcome Measure Information:
Title
Diagnostic accuracy of EDTU
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
same measures of diagnostic accuracy in the planned subgroup of patients being investigated for suspected renal colic
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric A Bruder, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kieran M Moore, MD MMSc
Organizational Affiliation
Queen's University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Louise Rang, MD RDMS
Organizational Affiliation
Queen's University
Official's Role
Study Director
Facility Information:
Facility Name
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Emergency Department Targeted Ultrasound for the Detection of Hydronephrosis

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