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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01123798
First Posted: May 14, 2010
Last Update Posted: June 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
United States Department of Defense
Somanetics Corporation
Information provided by:
J&M Shuler
  Purpose
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 Intervention
Acute Compartment Syndrome Device: near-infrared spectroscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Injured Soldiers

Resource links provided by NLM:


Further study details as provided by J&M Shuler:

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

Estimated Enrollment: 300
Study Start Date: February 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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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 Submitted: February 17, 2010
First Posted: May 14, 2010
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