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

NCT03604029 | Unknown FDA Device

• 1 other identifier: W81XWH17C0029
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Compartment Syndrome of Leg

Keywords

ACS

Outcome Measures

Primary Outcomes (1)

• Acute Compartment Syndrome

  The subject develops and diagnosed with Acute Compartment Syndrome

  Zero to seventy two hours from enrollment.

Study Arms (2)

Qualifying Subjects

Qualifying subjects who are high risk for ACS.

Device: Near Infrared Spectroscopy

Qualifying Subjects with ACS

Qualifying subjects who are diagnosed with ACS

Device: Near Infrared Spectroscopy

Interventions

Near Infrared Spectroscopy DEVICE

Near Infrared Spectroscopy (NIRS) sensors are applied to injured leg compartments and a control compartment to continuously measure tissue oxygenation.

Qualifying Subjects; Qualifying Subjects with ACS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Aged 18 to 65 years
• Ability to be enrolled within 12 hours of qualifying injury
• Must have at least one uninjured upper or lower extremity
• Must have a "severe leg injury" meeting one of the following anatomical locations and mechanisms of injury.
• Anatomic Location:
• Tibia/fibula shaft fracture
• Tibial plateau fracture (including lateral split depression, lateral depression, medial plateau, bicondylar, and bicondylar with metaphyseal extension)
• Gunshot wound to leg without tibia fracture
• High Energy Mechanism of Injury (MOI):
• Fall from more than 5-foot height
• Motor vehicle collision (more than 15mph)
• Motor vehicle versus pedestrian accident
• High velocity gunshot wound (with or without tibia fracture)
• Crush injury
• Sport/recreation

You may not qualify if:

• Application of NIRS monitoring would be an impediment to care
• Known prior injury, surgery, or disease of the lower extremity (including thigh) that alters normal circulation in the leg (including peripheral vascular disease)
• Admission for atraumatic medical reasons (i.e. myocardial infarction, sepsis)
• Consent cannot be obtained from the patient or their LAR within 12 hours of injury
• Has already undergone fasciotomy of the injured leg prior to enrollment
• Has spinal injuries that result in complete loss of function (complete spinal cord injuries)
• Has bilateral upper and lower extremity injuries greater than simple soft tissue injuries
• Is in police custody at presentation to the hospital
• Is a woman who is pregnant
• 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).

Sponsors & Collaborators

• Nonin Medical, Inc: lead

Study Sites (1)

Brett A. Freedman, Col, MD

Rochester, Minnesota, 55901, United States

Location

Related Publications (2)

• 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.

  PMID: 26837078 RESULT

• 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.

  PMID: 29855235 RESULT

MeSH Terms

Interventions

Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Chevas R. Yeoman, MPH

  The Geneva Foundation

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: July 27, 2018
• Study Start: January 7, 2019
• Primary Completion: June 30, 2021
• Study Completion: February 28, 2022
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)