CompletedNot Applicable

Reliability of Sensor Spacing for NIRS in Traumatic Tibia Fractures

United States14 participantsStarted 2014-12

Plain-language summary

This is a study intended to evaluate a non-invasive device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs in specific situations. The name of this technology is NIRS (near-infrared spectroscopy). The goal of this study is to collect the information necessary to understand the use of the NIRS monitoring system to diagnose and direct treatment decisions in case of complications sometimes experienced in traumatic tibia fracture, such as excessive swelling called acute compartment syndrome (ACS).

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Unilateral leg injury * Enrolled within 48 hours of injury * Subjects with 'severe' leg injuries presenting at trauma center that meet at least one of the following from each group below: Anatomic location: * Tibia/Fibula shaft fracture * Tibial plateau fracture (Schatzker III-VI) High Energy Mechanism of Injury: * Fall from \>8 foot height * Motor vehicle collision (\> 15 mph) * Motor vehicle versus pedestrian accident * High velocity gunshot wound * Crush injury * Sport/recreation Exclusion Criteria: * Application of NIRS monitoring would be an impediment to care * Known prior leg fractures, patient has already undergone fasciotomy of the injured leg prior to enrollment * History of peripheral vascular disease or concurrent lower extremity vascular injury/surgery * Admission for atraumatic medical reasons * Subject is unable to provide informed consent, or consent cannot be obtained from a legally authorized representative * Complete spinal cord injuries, bilateral upper extremity injuries, or amputation/mangled lower extremity * Patients who are in police custody at presentation to the hospital or who are pregnant * Patient has an open injury on the injured leg that is large enough that at least one NIRS sensor cannot be safely placed over the compartment * Bilateral leg injuries * Not able to be enrolled within 48 hours after injury

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

NIRS measurements as compared to clinical findings

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 72 hours

Trial details

NCT IDNCT02301832

SponsorEmory University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-07-20

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