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

NCT01123798 | Completed

• 1 other identifier: DR080018-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Compartment Syndrome

Keywords

near infrared spectroscopy; lower extremity injury

Outcome Measures

Primary Outcomes (1)

• NIRS values in various physiologic states (stable control, critically injured control, lower extremity injury)

  24-48 hours from hospital admission

Study Arms (3)

Stable controls

Uninjured soldiers to provide normative data for stable physiological status

Device: near-infrared spectroscopy

Critical controls

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.

Device: near-infrared spectroscopy

Lower extremity trauma

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

Device: near-infrared spectroscopy

Interventions

near-infrared spectroscopy DEVICE

Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.

Critical controls; Lower extremity trauma; Stable controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Active duty OIF/OEF military personnel who have been air evacuated from theater to Landstuhl Regional Medical Center (LRMC). Ambulatory, self-care volunteers from the LRMC outpatient spine center will be identified to serve as controls for Cohort 1.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• J&M Shuler: lead
• United States Department of Defense: collaborator
• Somanetics Corporation: collaborator

Study Sites (1)

Landstuhl Regional Medical Center

Landstuhl, Germany

Location

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

• Brett Freedman, MD

  Landstuhl Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: May 14, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: June 15, 2011

Record last verified: 2011-06

Locations

DE (1)