Back to resultsEffect of Emergency Department Bedside Compression Ultrasonography on Door-to-Disposition Time in Patients Suspicious for Lower Extremity Deep Venous Thrombosis
Primary Purpose
Lower Extremity Deep Vein Thrombosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bedside Compression Ultrasonography
Sponsored by
About this trial
This is an interventional diagnostic trial for Lower Extremity Deep Vein Thrombosis
Eligibility Criteria
Inclusion Criteria: Emergency Department patients presenting for lower extremity swelling concerning Deep vein thrombosis. - Exclusion Criteria: n/a -
Sites / Locations
- Henry Ford Wyandotte Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Active
Arm Description
Outcomes
Primary Outcome Measures
Time to disposition
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.
Secondary Outcome Measures
Accuracy of POCUS vs formal LE doppler
We examined the accuracy of POCUS vs formal doppler in making the diagnosis of lower extremity deep vein thrombosis.
Full Information
NCT ID
NCT05682040
First Posted
December 14, 2022
Last Updated
January 9, 2023
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT05682040
Brief Title
Effect of Emergency Department Bedside Compression Ultrasonography on Door-to-Disposition Time in Patients Suspicious for Lower Extremity Deep Venous Thrombosis
Official Title
Effect of Emergency Department Bedside Compression Ultrasonography on Door-to-Disposition Time in Patients Suspicious for Lower Extremity Deep Venous Thrombosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparing the disposition time of point of care ultrasound (POCUS) versus formal lower extremity doppler in emergency department patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Extremity Deep Vein Thrombosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Bedside Compression Ultrasonography
Intervention Description
Point of Care Ultrasound (Bedside Compression Ultrasonography) vs formal lower extremity Doppler
Primary Outcome Measure Information:
Title
Time to disposition
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Accuracy of POCUS vs formal LE doppler
Description
We examined the accuracy of POCUS vs formal doppler in making the diagnosis of lower extremity deep vein thrombosis.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Emergency Department patients presenting for lower extremity swelling concerning Deep vein thrombosis.
-
Exclusion Criteria: n/a
-
Facility Information:
Facility Name
Henry Ford Wyandotte Hospital
City
Wyandotte
State/Province
Michigan
ZIP/Postal Code
48192
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Emergency Department Bedside Compression Ultrasonography on Door-to-Disposition Time in Patients Suspicious for Lower Extremity Deep Venous Thrombosis
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