Bioimpedance for Injury

Overseen By Holly B Symonds

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Metatarsal fractures, Implanted devices, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Bioimpedance Imaging for injury?

Research shows that bioimpedance imaging can help identify changes in soft tissue after injuries, such as in soccer players, by measuring fluid accumulation and tissue damage. This suggests it could be useful in understanding and monitoring injury recovery. ^{1 2 3 4 5}

Is bioimpedance generally safe for use in humans?

Bioimpedance is a non-invasive method that uses electrical measurements to assess body tissues, and it has been used safely in various studies, including those involving muscle injuries and burn patients. The technique is generally considered safe, with no significant safety concerns reported in the research provided. ^{1 3 6 7 8}

How is Bioimpedance Imaging different from other treatments for injury?

Bioimpedance Imaging is unique because it uses electrical signals to measure the resistance and reactance of body tissues, providing insights into tissue composition and hydration status. This non-invasive method can offer real-time data on changes in the body, which is different from traditional imaging techniques that may not provide such detailed physiological information. ^{1 2 9 10 11}

What is the purpose of 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.

Research Team

Ida L Gitajn, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

This trial is for adults over 18 with a high-energy closed fracture in one limb. They must be able to give informed consent. It's not for those with injuries to both lower limbs, implanted electronic devices, or pregnant/lactating women.

Inclusion Criteria

I have a severe break in a limb bone.

Provision of informed consent

Exclusion Criteria

I have injuries to both legs that prevent imaging of the opposite side.

I have a broken bone in my foot.

Presence of an implanted electronic device (e.g. pacemaker, vagal stimulator, deep brain stimulator) or electrodes or electrical wires

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Patients undergo imaging with an EIT device in various clinical settings

20 minutes per session

Multiple sessions in Emergency Department, Operating Room, Orthopaedic Clinic, and In-patient hospital rooms

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• Bioimpedance Imaging

Trial Overview The study tests an electrical impedance tomography (EIT) device on patients with severe limb injuries. The EIT imaging will be done in various settings like the ER, operating room, orthopedic clinic, and hospital rooms.

Participant Groups

Group I: Extremity fracture Experimental Treatment 1 Intervention

High energy closed extremity fractures

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Changes in body composition of burn patients during the phases of response to trauma. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Estimation of total body and extracellular water in post-coronary artery bypass graft surgical patients using single and multiple frequency bioimpedance. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Localized BIA identifies structural and pathophysiological changes in soft tissue after post-traumatic injuries in soccer players. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Bioimpedance measurement based evaluation of wound healing. [2018]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Prediction of treatment outcome with bioimpedance measurements in breast cancer related lymphedema patients. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Threshold and Trend Artifacts in Localized Multi-Frequency Bioimpedance Measurements. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Localized bioimpedance to assess muscle injury. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Surface Potential Simulation for Robust Electrode Placement by MRI Based Human Phantom with FEM Based Quasi-Static Solver for Bioimpedance Measurement. [2020]

9. England pubmed.ncbi.nlm.nih.gov

A framework for modeling bioimpedance measurements of nonhomogeneous tissues: a theoretical and simulation study. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

A Practical Method to Reduce Electrode Mismatch Artefacts during 4-electrode BioImpedance Spectroscopy Measurements. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Validation of bioimpedance spectroscopy to assess acute changes in hydration status. [2019]