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

NCT ID: NCT03604029

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-07
• Study Completion Date: 2022-02-28

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.

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.

Conditions

Compartment Syndrome of Leg

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Qualifying Subjects

Qualifying subjects who are high risk for ACS.

Near Infrared Spectroscopy

Intervention Type: DEVICE

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

Near Infrared Spectroscopy

Intervention Type: DEVICE

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

Interventions

Near Infrared Spectroscopy

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

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nonin Medical, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chevas R. Yeoman, MPH

Role: STUDY_DIRECTOR

The Geneva Foundation

William M. Reisman, MD

Role: PRINCIPAL_INVESTIGATOR

Emory Department of Orthopedics

Charles L. Ogburn, MD

Role: PRINCIPAL_INVESTIGATOR

Athens Orthopedic Clinic

Patrick M. Osborn, MD

Role: PRINCIPAL_INVESTIGATOR

San Anontio Military Medical Center

Brandon J. Yuan, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Brett A. Freedman, Col, MD

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 26837078 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29855235 (View on PubMed)

Other Identifiers

W81XWH17C0029

Identifier Type: -

Identifier Source: org_study_id