NCT05682040

Brief Summary

Comparing the disposition time of point of care ultrasound (POCUS) versus formal lower extremity doppler in emergency department patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

July 30, 2026

Completed
Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

8 months

First QC Date

December 14, 2022

Results QC Date

July 16, 2023

Last Update Submit

July 2, 2026

Conditions

Lower Extremity Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Time to Completion of Point of Care Ultrasound in Emergency Room and Lower Extremity Doppler Prior to Disposition

    Completion time in minutes for point of care ultrasound (POCUS) in the emergency department followed by formal lower extremity (LE) doppler in radiology department prior to patient disposition from emergency department.

    Emergency Department admission to Disposition from Emergency Department

Secondary Outcomes (1)

  • Accuracy of POCUS vs Formal Lower Extremity Doppler

    Upon completion of POCUS and formal lower extremity doppler until disposition from Emergency Department

Study Arms (1)

Active

OTHER
Diagnostic Test: Bedside Compression Ultrasonography

Interventions

Bedside Compression UltrasonographyDIAGNOSTIC_TEST

Point of Care Ultrasound (Bedside Compression Ultrasonography) vs formal lower extremity Doppler

Active

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Wyandotte Hospital

Wyandotte, Michigan, 48192, United States

Location

Limitations and Caveats

Power of study wasn't sufficient to determine reasonable sensitivity and specificity of bedside US.

Results Point of Contact

Title
Dr. Christopher Nedzlek
Organization
HenryFordHS
nedzlekc@gmail.com
17342236996

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2022

First Posted

January 12, 2023

Study Start

April 1, 2017

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

July 30, 2026

Results First Posted

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)