ClinConnect ClinConnect Logo
Search / Trial NCT02301832

Reliability of Sensor Spacing for NIRS in Traumatic Tibia Fractures

Launched by EMORY UNIVERSITY · Nov 25, 2014

Trial Information

Current as of June 18, 2025

Completed

Keywords

Acute Compartment Swelling (Acs) Near Infrared Spectroscopy (Nirs)

ClinConnect Summary

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 tissu...

Gender

ALL

Eligibility criteria

  • 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

About Emory University

Emory University, a leading research institution located in Atlanta, Georgia, is dedicated to advancing medical knowledge and improving patient care through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, Emory harnesses the expertise of its renowned faculty and state-of-the-art facilities to conduct cutting-edge research across various fields, including oncology, neurology, and infectious diseases. The university's commitment to ethical research practices and patient safety ensures that all clinical trials are designed to generate valuable data that can lead to significant therapeutic advancements. By fostering partnerships with local hospitals and community organizations, Emory strives to translate research findings into real-world applications, ultimately enhancing health outcomes for diverse populations.

Locations

Atlanta, Georgia, United States

Patients applied

0 patients applied

Trial Officials

William Reisman, MD

Principal Investigator

Emory University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials