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

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ClinicalTrials.gov Identifier: NCT01123798
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : June 15, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Acute Compartment Syndrome Device: near-infrared spectroscopy

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Injured Soldiers
Study Start Date : February 2010
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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.


Outcome Measures

Primary Outcome Measures :
  1. NIRS values in various physiologic states (stable control, critically injured control, lower extremity injury) [ Time Frame: 24-48 hours from hospital admission ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123798


Locations
Germany
Landstuhl Regional Medical Center
Landstuhl, Germany
Sponsors and Collaborators
J&M Shuler
United States Department of Defense
Somanetics Corporation
Investigators
Principal Investigator: Brett Freedman, MD Landstuhl Regional Medical Center
More Information

Responsible Party: Brett Freedman, MAJ MC (MD), Landstuhl Regional Medical Center
ClinicalTrials.gov Identifier: NCT01123798     History of Changes
Other Study ID Numbers: DR080018-01
First Posted: May 14, 2010    Key Record Dates
Last Update Posted: June 15, 2011
Last Verified: June 2011

Keywords provided by J&M Shuler:
near infrared spectroscopy
lower extremity injury

Additional relevant MeSH terms:
Syndrome
Compartment Syndromes
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases