Electrical bioimpedance imaging for high-energy limb fractures
A Pilot Study on the Technical Feasibility of an Electrical Impedance Tomography Device for Soft Tissue Injury Following High Energy Extremity Fractures
This will test whether a portable electrical impedance tomography (EIT) device can image tissue changes in adults with high-energy closed limb fractures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Locations | 1 site (Lebanon, New Hampshire) |
| Trial ID | NCT06858488 on ClinicalTrials.gov |
What this trial studies
Adults with high-energy closed extremity fractures will undergo bedside imaging with an electrical impedance tomography (EIT) device in the Emergency Department, Operating Room, Orthopaedic Clinic, and inpatient hospital rooms. EIT produces maps of tissue electrical properties that can reflect blood flow, swelling, and other changes in injured tissue. Imaging will be repeated across care settings to track changes before, during, and after surgical intervention. Patients with implanted electronic devices, metatarsal fractures, bilateral lower-limb injuries preventing contralateral imaging, or who are pregnant or lactating are excluded.
Who should consider this trial
Good fit: Adults aged 18 or older with a high-energy closed extremity fracture who can give informed consent and do not have implanted electronic devices, bilateral lower-limb injuries preventing contralateral imaging, metatarsal-only fractures, or pregnancy/lactation are ideal candidates.
Not a fit: Patients with metatarsal fractures, implanted electronic devices, bilateral lower-extremity injuries that prevent contralateral imaging, or who are pregnant or lactating would be excluded and therefore would not receive benefit from participation.
Why it matters
Potential benefit: If successful, this could provide a noninvasive bedside way to detect perfusion or swelling problems earlier, potentially allowing faster treatment and reducing the risk of limb damage.
How similar studies have performed: Electrical impedance tomography has shown promise in pulmonary and peripheral perfusion research, but its application to high-energy orthopedic trauma is relatively novel with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lebanon, New Hampshire
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (Recruiting)
Study contacts
- Principal investigator: Ida L Gitajn, MD — Dartmouth-Hitchcock Medical Center
- Study coordinator: Holly B Symonds
- Email: Holly.B.Symonds@hitchcock.org
- Phone: 603-653-9440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.