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Reliability of Sensor Spacing for NIRS in Traumatic Tibia Fractures

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ClinicalTrials.gov Identifier: NCT02301832
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
William Reisman, Emory University

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).

Condition or disease
Orthopedic Disorders Tibial Fractures

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.

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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reliability of Sensor Spacing for Near Infrared Spectroscopy in Traumatic Tibia Fractures: An Observational Study
Actual Study Start Date : December 2014
Actual Primary Completion Date : July 20, 2016
Actual Study Completion Date : July 20, 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from the trauma bay, surgical wards and ICU of Grady Memorial Hospital.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301832


Locations
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United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: William Reisman, MD Emory University

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Responsible Party: William Reisman, William Reisman MD, Emory University
ClinicalTrials.gov Identifier: NCT02301832     History of Changes
Other Study ID Numbers: IRB00075483
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017

Keywords provided by William Reisman, Emory University:
acute compartment swelling (ACS)
near-infrared spectroscopy (NIRS)

Additional relevant MeSH terms:
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Fractures, Bone
Tibial Fractures
Musculoskeletal Diseases
Wounds and Injuries
Leg Injuries