Reliability of Sensor Spacing for NIRS in Traumatic Tibia Fractures

Completed

Brief 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).

Detailed Description: This study seeks to further develop the use of NIRS technology in the diagnosis of acute compartment syndrome. NIRS values normally increase in traumatized legs compared to the contralateral uninjured leg or forearm, indicative of a hyperemic response. The investigators hopes to build upon the current knowledge and verify the ability to accurately detect ACS using two easily identified and accessible leg compartments, the anterior and superficial posterior utilizing the Nonin 7600 oximeter with the Sensor Model 8004CV. Additionally, since this device was originally designed with brain tissue in mind, the NIRS device will collect vital engineering data that will be used to validate the algorithm used to produce the oxygenation values in injured muscle tissue.

Recruitment & Eligibility

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:

High Energy Mechanism of Injury:

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

Primary Outcome Measures

Name	Time	Method
NIRS measurements as compared to clinical findings	Participants will be followed for the duration of hospital stay, an expected average of 72 hours	Assess the accuracy of the Nonin 7600 oximeter with the Sensor Model 8004CV in the diagnosis of Acute Compartment Syndrome, using the "gold standard" criterion for ACS, which will be "clinical diagnosis". That is, all subjects undergoing fasciotomy for clinically diagnosed ACS will be considered to have ACS. NIRS values will be compared to clinical diagnosis to determine accuracy and threshold values.

Secondary Outcome Measures

Name	Time	Method
Accuracy of NIRS measurements compared to Intracompartmental pressure (ICP) measurements	Participants will be followed for the duration of hospital stay, an expected average of 72 hours	ICP measurements will be compared to NIRS values to assess the magnitude of accuracy between the 2 tools.
Correlation between NIRS measurements between injured and uninjured extremity	Participants will be followed for the duration of hospital stay, an expected average of 72 hours	Compare NIRS values between non-injured and injured extremities

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