Efficient Anterior Shoulder Ultrasound Reduction Multicenter Prospective Randomized Trial

Not Applicable

Terminated

• Conditions: Shoulder Dislocation
• Interventions: Diagnostic Test: X-Ray; Diagnostic Test: Ultrasound

• Registration Number: NCT04820491
• Lead Sponsor: Virginia Commonwealth University

Brief 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.

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 Timeline

• Study First Submitted: 2021-03-25
• Study Start: 2021-03-26
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-03-29
• Primary Completion: 2021-10-21
• Study Completion: 2021-10-21
• Status Verified: 2022-10
• Results First Submitted: 2022-10-21
• Results First Submitted QC: 2022-10-21
• Last Update Submitted: 2022-10-21
• Results First Posted: 2022-11-16
• Last Update Posted: 2022-11-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
X-Ray	X-Ray	-
Ultrasound	Ultrasound	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to Diagnosis	up to 8 hours or time to admission	Time to diagnosis will be calculated from time of first provider contact to time of x-ray or time of ultrasound per treatment condition
Total Number of Xrays	up to 8 hours or time to admission	Total number of xrays ordered during time in ED
Patient Satisfaction	at discharge or admission - up to 8 hours	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).
Confirmation of Reduction	up to 8 hours or time to admission	As documented by x-ray or ultrasound per treatment condition
Cost of Treatment	up to 8 hours or time to admission	Calculated as total billing cost of procedures related to shoulder dislocation ED visit

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States