Emergency Department Targeted Ultrasound for the Detectio... | NCT00555308

Studies
Emergency Department Targeted Ultrasound for the Detection of Hydronephrosis

NCT00555308

Sponsor

Queen's University

Status

Completed

Last Update Posted

Jul 22, 2009Estimated

Enrollment

200Actual

Phase

Not Applicable

Conditions

Urolithiasis
Ultrasonography
Hydronephrosis

Interventions

emergency department targeted ultrasound imaging

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PSI Grant Sept 2007

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Nov 7, 2007

First Submission Date that Met QC Criteria

Nov 7, 2007

First Posted Date

Nov 8, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2009

Last Update Posted Date

Jul 22, 2009Estimated

Name	Class
The Physicians' Services Incorporated Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
one	Experimental	undergo EDTU	Other: emergency department targeted ultrasound imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
emergency department targeted ultrasound imaging	Other	bedside ultrasound performed by emergency physician to identify hydronephrosis	one

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic accuracy of EDTU		1 hour

Secondary Outcomes

Measure	Description	Time Frame
same measures of diagnostic accuracy in the planned subgroup of patients being investigated for suspected renal colic		1 hour

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hotel Dieu Hospital		Kingston	Ontario	K7L 2V7	Canada
Kingston General Hospital

Condition Browse Module

MeSH Terms

ID	Term
D052878	Urolithiasis
D006869	Hydronephrosis

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided