Bioimpedance for Ortho Trauma
ConditionTrauma Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
High energy closed extremity fracture
Provision of informed consent
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Extremity Surgery
Procedure/SurgeryPatients 18 years of age or older with high energy closed extremity fractures. Provision of informed consent.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Extremity fractureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility and acceptability of the EIT device
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.
Time frame
20 minutesSponsors and contacts
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Dartmouth-Hitchcock Medical Center
Lead sponsor
Dartmouth College
Collaborator
Source ClinicalTrials.gov