Clinical Trial: The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome

Brief Summary:

This is a prospective observational study to determine the reliability and accuracy of Near Infrared Spectroscopy (NIRS) to detect oxygen flow in the extremities of injured and non-injured soldiers over time. This technology may be useful in the detection of acute compartment syndrome. We hypothesize that:

  • NIRS values will be well-correlated with intracompartmental pressure measurements
  • NIRS values will be significantly different between non-injured and injured extremities, and injured extremities treated with fasciotomy for acute compartment syndrome.
  • NIRS values of the upper extremity and feet will correlate to values from normal legs in critical control patients and patients with unilateral sever lower extremity injuries.

Detailed Summary:

The purpose of this prospective observational cohort 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. Additionally, it will establish diagnostic perfusion value thresholds to be used in a subsequent interventional study confirming the efficacy of NIRS-based ACS monitoring. Through prospective measurements of NIRS values, vital signs, intracompartmental pressures and clinical examinations, guidelines and parameters will be established for the use of NIRS in diagnosing acute compartment syndrome (ACS), monitoring patients at risk for ACS and evaluating the adequacy of fasciotomy in patients treated for ACS.

Null hypotheses:

  • NIRS values do not correlate with intracompartmental pressures, when they are obtained in the course of routine care of patients in the combat theater.
  • There is no difference in the NIRS values between non-injured, injured extremities and injured extremities treated with fasciotomy for ACS
  • NIRS values from the upper extremity and feet do not correlate to NIRS values from the normal legs in critical control patients and patients with unilateral severe lower extremity injury.

Specific Aims:

  1. Conduct observational, human-use, study to compile a normative reference database for NIRS-measured tissue perfusion in the uninjured upper extremity and the injured and non-injured legs of up to 120 injured subjects, from varying ethnicities (skin pigmentations) in varying degrees of hemodynamic st
    Sponsor: J&M Shuler

    Current Primary Outcome: Incidence of acute compartment syndrome (ACS) [ Time Frame: 24-48 hours at study site ]

    The "gold standard" criterion for ACS will be "clinical diagnosis". That is, all subjects undergoing fasciotomy for clinically diagnosed ACS (NOT PROPHYLACTIC fasciotomies) will be considered to have ACS. NIRS values will be compared to clinical diagnosis to determine accuracy and threshold values.


    Original Primary Outcome: Incidence of acute compartment syndrome (ACS) [ Time Frame: 24-48 hours at CSH + 24-28 hours at LRMC ]

    The "gold standard" criterion for ACS will be "clinical diagnosis". That is, all subjects undergoing fasciotomy for clinically diagnosed ACS (NOT PROPHYLACTIC fasciotomies) will be considered to have ACS. NIRS values will be compared to clinical diagnosis to determine accuracy and threshold values.


    Current Secondary Outcome: Intracompartmental pressure (ICP) [ Time Frame: 24-48 hours at study site ]

    ICP measurements will be taken at the doctor's discretion, as this is the only existing objective diagnostic tool for ACS. When available, ICP will be compared to NIRS values to assess the magnitude of agreement between the 2 tools.


    Original Secondary Outcome: Intracompartmental pressure (ICP) [ Time Frame: 24-48 hours at CSH ]

    ICP measurements will be taken at the doctor's discretion, as this is the only existing objective diagnostic tool for ACS. When available, ICP will be compared to NIRS values to assess the magnitude of agreement between the 2 tools.


    Information By: J&M Shuler

    Dates:
    Date Received: July 27, 2010
    Date Started: September 2011
    Date Completion: December 2012
    Last Updated: June 14, 2011
    Last Verified: June 2011