Bioimpedance for Ortho Trauma

Not Applicable

Not yet recruiting

• Conditions: Trauma Injury

• Registration Number: NCT06858488
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-02-27
• Study First Posted: 2025-03-05
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Study Start: 2025-06
• Primary Completion: 2026-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility and acceptability of the EIT device	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.

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States