The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Injured Soldiers

J&M Shuler

Status: Completed

Conditions: Acute Compartment Syndrome

Treatments: Device: near-infrared spectroscopy

Study type: Observational

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT01123798

DR080018-01

Details and patient eligibility

About

The purpose of this study is to define the reliability and accuracy of Near Infrared Spectroscopy (NIRS) in the detection of intra-compartmental tissue perfusion in injured and noninjured extremities over time. The investigators hypothesize that this technology, combined with vital signs, intracompartmental pressures and clinical examinations, will be useful in diagnosing acute compartment syndrome (ACS), monitoring patients at risk for ACS, and evaluating the adequacy of fasciotomy in patients treated for ACS.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18-65 years old
• male or female
• active duty servicemen who have been evacuated from OIF or OEF through LRMC

Exclusion criteria

• patients not willing to provide consent
• patients in whom application of NIRS monitoring is viewed as an impediment to casualty care

Trial design

300 participants in 3 patient groups

Stable controls

Description:

Uninjured soldiers to provide normative data for stable physiological status

Treatment:

Device: near-infrared spectroscopy

Critical controls

Description:

Critically injured soldiers with no lower extremity traumatic injuries (excepting skin abrasions and small/superficial fragmentation wounds) to provide normative data for the "shock" physiological status.

Treatment:

Device: near-infrared spectroscopy

Lower extremity trauma

Description:

Soldiers with severe traumatic lower extremity injuries in stable and shock physiologic status. This is the investigational cohort.

Treatment:

Device: near-infrared spectroscopy