- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02369263
DVT Ultrasound in the Emergency Department
February 17, 2015 updated by: Emergency Medicine Physicians, Nevada
An Observational Study of Emergency Medicine Resident Performed Ultrasonography for DVT.
Emergency Medicine (EM) Residents routinely conduct bedside ultrasound exams in the Emergency Department (ED) employing the two point compression method.
This study endeavors to investigate the accuracy and utility of bedside ultrasound for Deep Vein Thrombosis (DVT) in the ED by EM Residents by comparing the results of that exam against the gold standard of a DVT ultrasound performed in the Radiology Department and interpreted by a Radiologist.
Study Overview
Status
Completed
Conditions
Detailed Description
For subjects with suspicion of DVT to the Emergency Department, an EM Resident will perform a bedside non-diagnostic two point compression DVT Ultrasound.
Subjects will then receive a diagnostic DVT Ultrasound in the Radiology Department with official radiologist interpretation.
The bedside ultrasound will not interfere with or delay the diagnostic ultrasound.
Patient demographic and clinical data will be collected for validation purposes.
Validation of the The EM Resident interpretation will be accomplished by comparison to the official Radiologist interpretation.
Study Type
Observational
Enrollment (Actual)
288
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Nevada
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Las Vegas, Nevada, United States, 89102
- University Medical Center of Southern Nevada
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients presenting to the Emergency Departmetn suspicious of DVT
Description
Inclusion Criteria:
- Age 18 or older
- Suspect of having DVT
Exclusion Criteria:
- Known DVT
- DVT with in previous 6 months
- DVT Ultrasound within the last 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Outcome measures is the proportion of agreement between Resident performed two point DVT ultrasaound and the Radiologist interpertation of a formal DVT ultrasound.
Time Frame: 5 minutes
|
Two point Emergency Medicine Resident preformed DVT Ultrasound (5 minute procedure) results will be compared as a proportion to Radiologist interpreted ultrasonographer performed DVT Ultrasound results.
|
5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jamie Baydoun, MD, Emergency Medicine Physicians
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
April 11, 2013
First Submitted That Met QC Criteria
February 17, 2015
First Posted (Estimate)
February 23, 2015
Study Record Updates
Last Update Posted (Estimate)
February 23, 2015
Last Update Submitted That Met QC Criteria
February 17, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMP2013-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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