Efficient Anterior Shoulder Ultrasound Reduction Multicenter Prospective Randomized Trial

Shoulder Dislocation Clinical Trial

— EASiUR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04820491
• Other study ID #: HM20019991
• Status: Terminated
• Phase: N/A
• Start date: March 26, 2021
• Est. completion date: October 21, 2021

Study information

• Verified date: October 2022
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: October 21, 2021
• Est. primary completion date: October 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Dislocation

Intervention

Diagnostic Test:
• X-Ray
Shoulder x-rays as felt necessary for standard of care of diagnosis of shoulder dislocation and reduction
• 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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Confirmation of Reduction	As documented by x-ray or ultrasound per treatment condition	up to 8 hours or time to admission
Secondary	Cost of Treatment	Calculated as total billing cost of procedures related to shoulder dislocation ED visit	up to 8 hours or time to admission
Secondary	Total Number of Xrays	Total number of xrays ordered during time in ED	up to 8 hours or time to admission