Skip to main content
OpenTrials
Completed

NCT Number: NCT02301832

Reliability of Sensor Spacing for NIRS in Traumatic Tibia Fractures

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Orthopedic Disorders Fractures, Bone Leg Injuries Musculoskeletal Diseases Tibial Fractures Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. NIRS measurements as compared to clinical findings

    Time frame: 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 outcomes

  1. Accuracy of NIRS measurements compared to Intracompartmental pressure (ICP) measurements

    Time frame: 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.

  2. Correlation between NIRS measurements between injured and uninjured extremity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Reliability of Sensor Spacing for Near Infrared Spectroscopy in Traumatic Tibia Fractures: An Observational Study

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 26, 2014
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.