A Pilot Study on the Technical Feasibility of an Electrical Impedance Tomography Device for Soft Tissue Injury Following High Energy Extremity Fractures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Feasibility and acceptability of the EIT device
Study Overview
Brief Summary
Patients with high-energy extremity trauma will undergo imaging with an EIT device in the Emergency Department, Operating Room, Orthopaedic Clinic, and In-patient hospital rooms. The EIT device is an electrical impedance tomography system.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or older
- •High energy closed extremity fracture
- •Provision of informed consent
Exclusion Criteria
- •Metatarsal fractures
- •Injury to both lower extremities precluding contralateral imaging
- •Presence of an implanted electronic device (e.g. pacemaker, vagal stimulator, deep brain stimulator) or electrodes or electrical wires.
- •Currently pregnant, potentially pregnant, or lactating women
Arms & Interventions
Extremity fracture
High energy closed extremity fractures
Intervention: Extremity Surgery (Procedure)
Outcomes
Primary Outcomes
Feasibility and acceptability of the EIT device
Time Frame: 20 minutes
The primary objective of this work is to explore whether changes in impedance measurement associated with EIT are associated with soft tissue injury and readiness for surgical intervention. EIT is a technique which introduces a small amount of electrical current into biologic tissue through an array of electrodes and measures the change in signal to generate images related to the physiology of that tissue.
Secondary Outcomes
No secondary outcomes reported
Investigators
Ida Leah Gitajn
Section Chief, Orthopaedics
Dartmouth-Hitchcock Medical Center