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

June 14, 2011 updated by: J&M Shuler
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Landstuhl, Germany
        • Landstuhl Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stable controls
Uninjured soldiers to provide normative data for stable physiological status
Device: near-infrared spectroscopy
Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.
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
Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.
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
Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
NIRS values in various physiologic states (stable control, critically injured control, lower extremity injury)
Time Frame: 24-48 hours from hospital admission
24-48 hours from hospital admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

J&M Shuler

Collaborators

United States Department of Defense
Somanetics Corporation

Investigators

  • Principal Investigator: Brett Freedman, MD, Landstuhl Regional Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

February 17, 2010

First Submitted That Met QC Criteria

May 13, 2010

First Posted (Estimate)

May 14, 2010

Study Record Updates

Last Update Posted (Estimate)

June 15, 2011

Last Update Submitted That Met QC Criteria

June 14, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR080018-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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