The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Trauma Patients (NIRS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01547013
First received: March 1, 2012
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

This is a study intended to evaluate a new device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations. The name of this technology is NIRS (near-infrared spectroscopy). This is a prospective observational cohort study intended to gather data using NIRS among injured and noninjured extremities over time. Additionally, this data will help in establishing diagnostic perfusion value thresholds to be used in a subsequent interventional study confirming the efficacy of NIRS-based ACS monitoring.


Condition
Anterior Tibial Compartment Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Phase II The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Trauma Patients

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • ACS [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: February 2012
Estimated Study Completion Date: May 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
COHORT 1
Critical Controls: Twenty five (25) critically injured subjects with NO "severe" traumatic lower extremity traumatic injuries to provide control data for critically injured physiological status, a state which may induce systemic, vs. regional hypoperfusion. ("Critical" CONTROLS)
COHORT 2
Ninety five (95) total (35 Cohort 2A; 35 Cohort 2B; 25 Cohort 2C) subjects with "severe leg injuries" presenting to a participating level 1 trauma center within 12 hours of their injury, to provide data on the acute post-injury phase. (STUDY COHORT)
COHORT 2A
Subjects meeting COHORT 2 inclusion criteria, who have UNILATERAL "severe leg injuries". Unilateral injuries include patients who meet the inclusion criteria for a "severe lower extremity injury" for ONE lower extremity, with no more than a simple soft tissue injury (eg, simple laceration) on the contralateral leg.
COHORT 2B:
Subjects meeting COHORT 2 inclusion criteria, who have BILATERAL lower extremity injuries, with at least one being a "severe leg injury". Bilateral injury patients include patients with at least one lower extremity injury classified as "severe" based on Cohort 2 inclusion criteria, with a contralateral injury greater than a simple soft tissue injury, including femur, foot, and crush injuries. Note that it is not necessary for both lower extremity injuries to meet the inclusion criteria to be enrolled in this cohort.
COHORT 2C
Subjects meeting COHORT 2 inclusion criteria, clinically diagnosed by the treating provider using that treating provider's standards of diagnosing ACS, and in addition to being diagnosed with ACS, the subject undergoes four-compartment leg fasciotomy. data collection to start BEFORE fasciotomy and continue AFTER fasciotomy.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults who have sustained major blunt and penetrating trauma, who present to Grady Memorial Hospital, Atlanta Medical Center, or Athens Regional Medical Center for treatment meeting the inclusion and exclusion

Criteria

Inclusion Criteria:

  • 18-60 years of age
  • Admitted to a participating trauma center (Grady, AMC, ARMC) within 12 hours of injury
  • At least one uninjured upper extremity
  • Patients enrolled in Cohort 2 will have a "severe leg injury" (must be one of the following locations and MOI):

    1. Anatomic Location:

  • Tibia/fibula shaft fracture
  • Tibial plateau fracture (Schatzker III-VI) 2. High Energy Mechanism of Injury (MOI):
  • Fall from >8 foot height
  • Motor vehicle collision (>15mph)
  • Motor vehicle versus pedestrian accident
  • High velocity gunshot wound
  • Crush injury
  • Sport/recreation
  • Patients enrolled in Cohort 1 will meet the criteria listed below:

    1. No bony or vascular lower extremity injury (including femur or foot fractures)
    2. Admitted to the ICU for a traumatic injury (not a medical problem, such as a heart attack)
    3. ICU stay for at least 48 hours(patients with < 2 hours of data will be excluded)

Patients will also be selected for each cohort (See Groups/Cohorts Section).

Exclusion Criteria:

  • NIRS monitoring impediment to care
  • Known prior leg fractures (not related to current injury)
  • Peripheral vascular disease history or concurrent lower extremity vascular injury/surgery
  • Admission for medical reasons - atraumatic (ie. myocardial infarction, sepsis…)
  • Less 18 years old or greater than 60 years old
  • Unable to provide informed consent, or consent cannot be obtained from a legally authorized representative, within 12 hours of injury or prior to first leg surgery, whichever comes first
  • Amputation/Mangled Lower Extremity
  • Previous fasciotomy history of the injured leg prior to enrollment
  • Complete spinal cord injuries
  • Bilateral upper extremity injuries
  • Participants who are in custody at presentation to the hospital
  • Pregnancy
  • Open injury on the injured leg that is large enough that at least one NIRS sensor cannot be safely placed over the compartment

    • Spanish-speaking subjects who do not speak English will NOT be excluded. A certified translated copy of the informed consent document will used and a translator will be present for Spanish-speaking patients.
  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: NCT01547013

Locations
United States, Georgia
Athens Regional Medical Center
Athens, Georgia, United States, 30606
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Atlanta Medical Center
Atlanta, Georgia, United States, 30312
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Brett Freedman, MD US Army Landstuhl Regional Medical Center
  More Information

No publications provided

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01547013     History of Changes
Other Study ID Numbers: S-11-20, A-15808.2
Study First Received: March 1, 2012
Last Updated: March 6, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Anterior Compartment Syndrome
Compartment Syndromes
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014