Effect of Emergency Department Bedside Compression Ultrasonography on Door-to-Disposition Time in Patients Suspicious for Lower Extremity Deep Venous Thrombosis

January 9, 2023 updated by: Christopher Nedzlek, Henry Ford Health System
Comparing the disposition time of point of care ultrasound (POCUS) versus formal lower extremity doppler in emergency department patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

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

  • United States
    • Michigan
      • Wyandotte, Michigan, United States, 48192
        • Henry Ford Wyandotte Hospital

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

Description

Inclusion Criteria: Emergency Department patients presenting for lower extremity swelling concerning Deep vein thrombosis.

-

Exclusion Criteria: n/a

-

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Active
Diagnostic test: Bedside Compression Ultrasonography
Point of Care Ultrasound (Bedside Compression Ultrasonography) vs formal lower extremity Doppler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to disposition
Time Frame: 3 months
We measured the time to disposition from the emergency department for point of care ultrasound (POCUS) vs formal lower extremity (LE) doppler in radiology department.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of POCUS vs formal LE doppler
Time Frame: 3 months
We examined the accuracy of POCUS vs formal doppler in making the diagnosis of lower extremity deep vein thrombosis.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

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 (Actual)

November 1, 2017

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

January 9, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11243 (Registry Identifier: DAIDS-ES)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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