Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
Somanetics Corporation
Information provided by:
J&M Shuler
ClinicalTrials.gov Identifier:
NCT01123798
First received: February 17, 2010
Last updated: June 14, 2011
Last verified: June 2011
  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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123798

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

No publications provided

Responsible Party: Brett Freedman, MAJ MC (MD), Landstuhl Regional Medical Center
ClinicalTrials.gov Identifier: NCT01123798     History of Changes
Other Study ID Numbers: DR080018-01
Study First Received: February 17, 2010
Last Updated: June 14, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014