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Bioimpedance for Ortho Trauma

A Pilot Study on the Technical Feasibility of an Electrical Impedance Tomography Device for Soft Tissue Injury Following High Energy Extremity Fractures

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06858488
Enrollment
30
Registered
2025-03-05
Start date
2025-03-20
Completion date
2028-07-01
Last updated
2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma Injury

Keywords

Orthopedics, Extremity fracture

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.

Interventions

PROCEDUREExtremity Surgery

Patients 18 years of age or older with high energy closed extremity fractures. Provision of informed consent.

Sponsors

Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER
Dartmouth College
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility and acceptability of the EIT device20 minutesThe 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.

Countries

United States

Contacts

CONTACTHolly B Symonds
Holly.B.Symonds@hitchcock.org603-653-9440
PRINCIPAL_INVESTIGATORIda L Gitajn, MD

Dartmouth-Hitchcock Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026