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Completed

NCT Number: NCT01123798

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Landstuhl Regional Medical Center

Landstuhl, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Near-infrared spectroscopy

Device

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

Primary outcomes

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

    Time frame: 24-48 hours from hospital admission

Sponsors and collaborators

Lead sponsor

J&M Shuler

Industry

Collaborators

  • Somanetics Corporation
  • United States Department of Defense

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 14, 2010
Registry last updated
Jun 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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