Deep Vein ThrombosisNCT02369263
DVT Ultrasound in the Emergency Department
An observational study of Deep Vein Thrombosis and DVT, run by Emergency Medicine Physicians, Nevada at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deep Vein Thrombosis, DVT
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients presenting to the Emergency Departmetn suspicious of DVT
Who may be able to join
- Age 18 or older
- Suspect of having DVT
Who cannot join
- Known DVT
- DVT with in previous 6 months
- DVT Ultrasound within the last 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
About this study
Official title: 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.
Read the 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.
- Conditions
- Deep Vein Thrombosis, DVT
- Keywords
- Deep Vein Thrombosis, DVT, Leg Swelling, Leg Pain, Blood Clot
- Medical subject headings
- Venous Thrombosis, Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome measures is the proportion of agreement between Resident performed two point DVT ultrasaound and the Radiologist interpertation of a formal DVT ultrasound.
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startMay 2013
- Primary completionJul 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergency Medicine Physicians, Nevada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamie Baydoun, MD, Principal investigator, Emergency Medicine Physicians
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369263
- Sponsor's protocol ID
- EMP2013-01
- Status last verified
- Feb 2015
- First submitted
- 11 Apr 2013
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Emergency Medicine Resident Performed Ultrasonography for DVT.
- ClinicalTrials.gov ID
- NCT02369263
- Acronym / sponsor ID
- EMP2013-01
- Conditions
- Deep Vein Thrombosis, DVT
- Keywords
- Deep Vein Thrombosis, DVT, Leg Swelling, Leg Pain, Blood Clot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Emergency Medicine Physicians, NevadaUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting to the Emergency Departmetn suspicious of DVT
Key inclusion criteria (2 listed)
- Age 18 or older
- Suspect of having DVT
Key exclusion criteria (3 listed)
- Known DVT
- DVT with in previous 6 months
- DVT Ultrasound within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie Baydoun, MD principal investigator
Emergency Medicine Physicians
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Vein Thrombosis and DVT, run by Emergency Medicine Physicians, Nevada at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2015.