Evaluating the Diagnostic Performance of ACS Using NIRS in Traumatized Lower Extremities

Evaluating the Diagnostic Performance of Near Infrared Spectroscopy (NIRS) in the Setting of Acute Compartment Syndrome (ACS) in Traumatized Lower Extremities

This is a study intended to validate a new set of guidelines for a device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations.

Study Overview

• Status: Unknown
• Conditions: Compartment Syndrome of Leg
• Intervention / Treatment: Device: Near Infrared Spectroscopy

Detailed Description

This is a study intended to validate a new set of guidelines for a device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations. The name of this technology is NIRS (near-infrared spectroscopy). We have shown NIRS can be helpful in diagnosing ACS. We think two of the primary advantages of this device are that it is noninvasive (not painful) and it collects data continuously, so that if the disease develops, it can be detected early and treated appropriately. We have studied the capabilities of NIRS for many years. The last step in the process of proving NIRS and its use in ACS will be to test our recommendations and guidelines. The goal of this study is to test and prove our clinical guidelines we developed through previous work. This is an interventional study, which means the data we collect will be used to manage the patient and their care.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55901
      • Brett A. Freedman, Col, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the trauma bay, surgical wards and ICU of the four participating facilities. This study will enroll approximately 300 subjects over four sites: Piedmont Athens Regional Medical Center, Grady Memorial Hospital, Mayo Clinic, and San Antonio Military Medical Center, over a period of approximately 24 months.

Description

Inclusion Criteria:

1. Aged 18 to 65 years
2. Ability to be enrolled within 12 hours of qualifying injury
3. Must have at least one uninjured upper or lower extremity
4. Must have a "severe leg injury" meeting one of the following anatomical locations and mechanisms of injury.

Anatomic Location:

1. Tibia/fibula shaft fracture
2. Tibial plateau fracture (including lateral split depression, lateral depression, medial plateau, bicondylar, and bicondylar with metaphyseal extension)
3. Gunshot wound to leg without tibia fracture

High Energy Mechanism of Injury (MOI):

1. Fall from more than 5-foot height
2. Motor vehicle collision (more than 15mph)
3. Motor vehicle versus pedestrian accident
4. High velocity gunshot wound (with or without tibia fracture)
5. Crush injury
6. Sport/recreation

Exclusion Criteria:

1. Application of NIRS monitoring would be an impediment to care
2. Known prior injury, surgery, or disease of the lower extremity (including thigh) that alters normal circulation in the leg (including peripheral vascular disease)
3. Admission for atraumatic medical reasons (i.e. myocardial infarction, sepsis)
4. Consent cannot be obtained from the patient or their LAR within 12 hours of injury
5. Has already undergone fasciotomy of the injured leg prior to enrollment
6. Has spinal injuries that result in complete loss of function (complete spinal cord injuries)
7. Has bilateral upper and lower extremity injuries greater than simple soft tissue injuries
8. Is in police custody at presentation to the hospital
9. Is a woman who is pregnant
10. Has open injury on the injured leg that is large enough that at least two NIRS sensor cannot be safely placed. At a minimum two sensors must be placed on the injured leg(s).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Qualifying Subjects; Qualifying subjects who are high risk for ACS.	Device: Near Infrared Spectroscopy; Near Infrared Spectroscopy (NIRS) sensors are applied to injured leg compartments and a control compartment to continuously measure tissue oxygenation.
Qualifying Subjects with ACS; Qualifying subjects who are diagnosed with ACS	Device: Near Infrared Spectroscopy; Near Infrared Spectroscopy (NIRS) sensors are applied to injured leg compartments and a control compartment to continuously measure tissue oxygenation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Compartment Syndrome	The subject develops and diagnosed with Acute Compartment Syndrome	Zero to seventy two hours from enrollment.

Collaborators and Investigators

• Sponsor: Nonin Medical, Inc
• Investigators: Study Director: Chevas R. Yeoman, MPH, The Geneva Foundation; Principal Investigator: William M. Reisman, MD, Emory Department of Orthopedics; Principal Investigator: Charles L. Ogburn, MD, Athens Orthopedic Clinic; Principal Investigator: Patrick M. Osborn, MD, San Anontio Military Medical Center; Principal Investigator: Brandon J. Yuan, MD, Mayo Clinic

Publications and helpful links

General Publications

• Reisman WM, Shuler MS, Roskosky M, Kinsey TL, Freedman BA. Use of Near-Infrared Spectroscopy to Detect Sustained Hyperaemia Following Lower Extremity Trauma. Mil Med. 2016 Feb;181(2):111-5. doi: 10.7205/MILMED-D-14-00689.
• Shuler MS, Roskosky M, Kinsey T, Glaser D, Reisman W, Ogburn C, Yeoman C, Wanderman NR, Freedman B. Continual near-infrared spectroscopy monitoring in the injured lower limb and acute compartment syndrome: an FDA-IDE trial. Bone Joint J. 2018 Jun 1;100-B(6):787-797. doi: 10.1302/0301-620X.100B6.BJJ-2017-0736.R3.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: ACS
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Musculoskeletal Diseases; Muscular Diseases; Syndrome; Compartment Syndromes
• Other Study ID Numbers: W81XWH17C0029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We do not plan to make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No