Efficient Anterior Shoulder Ultrasound Reduction Multicenter Prospective Randomized Trial (EASiUR)

EASiUR Trial: Efficient Anterior Shoulder Ultrasound Reduction Multicenter Prospective Randomized Trial

The purpose of the study is to determine if using ultrasound to diagnosis and confirm reductions of shoulder dislocations impacts the length of an emergency department visit for this condition.

Study Overview

• Status: Terminated
• Conditions: Shoulder Dislocation
• Intervention / Treatment: Diagnostic test: X-Ray; Diagnostic test: Ultrasound

Detailed Description

The purpose of the study is to determine if the length of the emergency department visit can be decreased and if patient exposure to x-rays can be reduced by utilizing an ultrasound to diagnose and confirm reduction in shoulder dislocations.

This study also seeks to determine if patients prefer ultrasound to x-ray when used to treat their shoulder dislocation.

Participants will be randomly assigned to one of two groups: either x-rays or ultrasound for the diagnosis and reduction confirmation of your shoulder dislocation.

Participant's shoulder dislocation will be treated per standard of care.

Participants will be asked to complete a short survey at the end of their visit.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

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:

1. Patients who are 18 years of age or older; and
2. Present to the VCU Emergency Department; and
3. Have clinical signs of uncomplicated shoulder dislocation; and
4. Agree to participation in the study; and
5. Provides a written consent to be included in the study.

Exclusion Criteria:

1. Patients who have a level 1 or 2 trauma activation, and/or;
2. Patients who are pregnant, incarcerated, or unable to consent, and/or;
3. Patients who have a past medical history of shoulder replacement in dislocated shoulder; and/or
4. Provider Discretion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: X-Ray	Diagnostic test: X-Ray; Shoulder x-rays as felt necessary for standard of care of diagnosis of shoulder dislocation and reduction
Active Comparator: Ultrasound	Diagnostic test: Ultrasound; Initial evaluation with ultrasound; may also evaluate nearby areas for concern of fracture. Order x- rays after ultrasound as seen fit for other injuries of diagnostic uncertainty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay in the Emergency Department (ED)	Length of stay in the ED will be calculated from time of first provider contact to time of discharge from the ED.	up to 8 hours or time to admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Patient satisfaction will be assessed using a 6 item scale. Each item is rated from 1 (extremely dissatisfied) to 5 (extremely satisfied). Scores are summed yielding scores ranging from 6 (most dissatisfied) to 30 (most satisfied).	at discharge or admission - up to 8 hours
Time to Diagnosis	Time to diagnosis will be calculated from time of first provider contact to time of x-ray or time of ultrasound per treatment condition	up to 8 hours or time to admission
Confirmation of Reduction	As documented by x-ray or ultrasound per treatment condition	up to 8 hours or time to admission
Cost of Treatment	Calculated as total billing cost of procedures related to shoulder dislocation ED visit	up to 8 hours or time to admission
Total Number of Xrays	Total number of xrays ordered during time in ED	up to 8 hours or time to admission

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Jordan Tozer, MD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2021
• Primary Completion (Actual): October 21, 2021
• Study Completion (Actual): October 21, 2021

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: HM20019991

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
• product manufactured in and exported from the U.S.: No