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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by J&M Shuler.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Nonin Medical
Information provided by:
J&M Shuler
ClinicalTrials.gov Identifier:
NCT01171638
First received: July 27, 2010
Last updated: June 14, 2011
Last verified: June 2011
  Purpose

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.

Condition Intervention
Acute Compartment Syndrome
Device: Near infrared spectroscopy (NIRS)

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

Resource links provided by NLM:


Further study details as provided by J&M Shuler:

Primary Outcome Measures:
  • Incidence of acute compartment syndrome (ACS) [ Time Frame: 24-48 hours at study site ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Intracompartmental pressure (ICP) [ Time Frame: 24-48 hours at study site ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Critical Controls
Critically injured patients with NO "severe traumatic lower extremity" injuries to provide normative data for the "critically injured" physiological status upon arrival at study site
Device: Near infrared spectroscopy (NIRS)
Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.
Other Name: Equanox Regional Oximeter, Nonin Medical, Plymouth, MN
Investigational cohort

Soldiers with "severe traumatic lower extremity" injuries in "stable" or "critical" physiological status presenting to a participating study site within 12 hours of their injury, to provide data on the acute post-injury phase. This cohort will be made up of:

  • Patients meeting inclusion criteria for investigational cohort, who have UNILATERAL "severe lower extremity injuries"
  • Patients meeting inclusion criteria for investigational cohort, who have BILATERAL "severe lower extremity injuries."
  • Patients meeting inclusion criteria for investigational cohort, who have been clinically diagnosed by the treating provider using that treating providers standards for diagnosing ACS and the patient in addition to be diagnosed with ACS undergoes four-compartment leg fasciotomy.
Device: Near infrared spectroscopy (NIRS)
Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.
Other Name: Equanox Regional Oximeter, Nonin Medical, Plymouth, MN

Detailed Description:

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 status (stable, critically injured) to test the 3 hypotheses listed above. The study groups consist of one control group (critically ill without leg injuries) and one investigational group (critically injured with leg injuries):

    • COHORT 1: 25 critically injured patients with NO severe traumatic lower extremity traumatic injuries to provide normative data for the "critically injured" physiological status ("Critical" CONTROLS)
    • COHORT 2: 95 total (35 Cohort 2A; 35 Cohort 2B; 25 Cohort 2C) patients with "severe" traumatic lower extremity injuries presenting to a "participating" level 1 trauma center within 12 hours of their injury, to provide data on the acute post-injury phase. (INVESTIGATIONAL COHORT)
    • COHORT 2A: Patients meeting COHORT 2 inclusion criteria, who have UNILATERAL "severe lower extremity injuries".
    • COHORT 2B: Patients meeting COHORT 2 inclusion criteria, who have BILATERAL "severe lower extremity injuries".
    • COHORT 2C (ACS GROUP): Patients meeting COHORT 2 inclusion criteria, who have been clinically diagnosed by the treating provider using that treating provider's standards of diagnosing ACS and the patient, in addition to being diagnosed with ACS, undergoes four-compartment leg fasciotomy. Patients in this cohort need data collection to start BEFORE fasciotomy and continue AFTER fasciotomy.
  2. Record provider comments regarding usability of the technology in its new embodiment and areas of needed design improvement. Apply this knowledge to perfect the industrial design and functionality of the final device.
  3. Establish evidenced-based clinical guidelines for the diagnosis and management of ACS in traumatically injured soldiers to be tested in a subsequent interventional clinical (IDE) study.
  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Critically injured patients (Cohort 1) or patients with severe lower extremity injuries (Cohort 2), admitted to one of the participating sites, who meet the eligibility criteria described below.

Criteria

Inclusion Criteria:

  • male or female subjects
  • between the ages of 15 and 65 years old
  • (Cohort 1 only) Admitted directly to the ICU of a participating study site
  • (Cohort 2 only) Admitted to a participating study site with the following injury/mechanism combinations:

Injuries:

  1. Segemental tibia shaft fracture
  2. Comminuted tibia shaft fracture
  3. Schatzker Type III-VI tibial plateau fractures

Mechanisms:

  1. Fall from a height of >= 8 feet
  2. Motor vehicle or motorcycle crash
  3. Pedestrian versus automobile

Exclusion Criteria:

  • Patients, in whom application of NIRS monitoring is viewed as an impediment to care.
  • Patients with known prior leg fractures (not related to current injury)
  • History of peripheral vascular disease or lower extremity vascular surgery.
  • Amputation
  • Diagnoses with ACS prior to enrollment
  • Spinal injuries resulting in complete loss of function
  • Mangled lower extremity
  • Bilateral upper extremity injuries
  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: NCT01171638

Contacts
Contact: Ashley Cole jandmshuler@gmail.com

Locations
United States, Georgia
Atlanta Medical Center Not yet recruiting
Atlanta, Georgia, United States
Principal Investigator: Bruce Ziran, MD         
Grady Memorial Hospital Not yet recruiting
Atlanta, Georgia, United States
Principal Investigator: William Reisman, MD         
Sponsors and Collaborators
J&M Shuler
Nonin Medical
Investigators
Principal Investigator: Brett Freedman, MD Landstuhl Regional Medical Center
Principal Investigator: William Reisman, MD Emory University
Principal Investigator: Bruce Ziran, MD Atlanta Medical Center
  More Information

No publications provided

Responsible Party: Brett Freedman, MAJ MC (MD), Landstuhl Regional Medical Center
ClinicalTrials.gov Identifier: NCT01171638     History of Changes
Other Study ID Numbers: DR080018-02
Study First Received: July 27, 2010
Last Updated: June 14, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by J&M Shuler:
near infrared spectroscopy
compartment syndrome
fasciotomy
INVOS

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

ClinicalTrials.gov processed this record on October 29, 2014