Ignite Creation Date:
2024-05-06 @ 3:29 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02301832
Status:
COMPLETED
Last Update Posted:
2017-02-06
First Post:
2014-11-24
Brief Title:
Reliability of Sensor Spacing for NIRS in Traumatic Tibia Fractures
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Reliability of Sensor Spacing for Near Infrared Spectroscopy in Traumatic Tibia Fractures An Observational Study
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None