Assessment of Near Infrared Spectroscopy as a Diagnostic Tool in Acute Compartment Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by J&M Shuler.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Emory University
Information provided by:
J&M Shuler
ClinicalTrials.gov Identifier:
NCT01077934
First received: February 24, 2010
Last updated: October 17, 2011
Last verified: October 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. We 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
Compartment Syndrome
Device: near-infrared spectroscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Near Infrared Spectroscopy as a Diagnostic Tool in Acute Compartment Syndrome

Resource links provided by NLM:


Further study details as provided by J&M Shuler:

Primary Outcome Measures:
  • NIRS values in lower leg extremity injury [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    We will monitor patients during their hospital stay from the time of admission until discharge at likey day 4.


Estimated Enrollment: 200
Study Start Date: November 2011
Groups/Cohorts Assigned Interventions
Injured Extremity without compartment syndrome Device: near-infrared spectroscopy
Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.
Injured extremity with compartment syndrome Device: near-infrared spectroscopy
Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.

Detailed Description:

Acute compartment syndrome (ACS) is associated with lower leg trauma in up to 20% of high energy injuries. ACS occurs when the pressure due to swelling exceeds the perfusion pressure thereby cutting off blood flow to the leg. If untreated, the results can be catastrophic with an insensate, contracted leg. Moreover, there is a high risk of subsequent infection and even amputation. The treatment for ACS, a four compartment fasciotomy, is aimed at releasing the pressure through two incisions from roughly the knee to the ankle. Often due to wound expansion, the incisions require multiple debridements and skin grafting to close. With fasciotomies, fractures are converted from closed to open injuries. When left open for many days, the risk of infection and complications such as nonunion increase significantly.

The only accepted objective method for diagnosis of ACS is to measure the pressure inside the leg compartments by using a large gauge needle hooked to a pressure monitor. However, these readings can be erroneous if not performed correctly. As such, ACS continues to be a clinical diagnosis which is made based on the surgeon's experience and their interpretation of the character of the injury (high-energy, motorcycle crash, vs. low-energy, a twisted ankle). Clinicians are left to attempt to interpret physical exam findings and readings from pressure monitors. Most importantly ACS is not an event, but a process that can manifest at multiple points after injury. The most accurate and effective method for diagnosing and appropriately treating ACS is serial examination over a course of hours to days.

With this study, we hope to evaluate the NIRS device, which is non-invasive, as diagnostic tool in the evaluation of acute compartment syndrome. We plan to evaluate all patients by the gold standard in diagnosing acute compartment syndrome while simultaneously evaluating the patient with the NIRS device. This will allow us to determine if the NIRS device can accurately and reliably predict the development of acute compartment syndrome in a non-invasive, longitudinal manner.

"Access to a precise, reliable, and noninvasive method for early diagnosis of ACS would be a landmark achievement in orthopaedic and emergency medicine."

  Eligibility

Ages Eligible for Study:   13 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All Patients admitted to Grady with Unilateral Lower leg injury at risk for compartment syndrome

Criteria

Inclusion Criteria:

  • Patients will be included between the ages of thirteen and eighty-five who are willing to participate and have unilateral lower leg injury with a fracture to the tibia.

Exclusion Criteria:

  • Patients will be excluded from enrollment if they have bilateral injuries to the lower legs or have been previously diagnosed peripheral vascular disease. Patients will also be excluded if they are not willing to participate.
  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: NCT01077934

Contacts
Contact: William M Reisman, MD 404-272-1637 wmreisman@gmail.com

Locations
United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30303
Contact: William Reisman    404-778-1550    wmreisman@emory.edu   
Principal Investigator: William M Reisman, MD         
Sponsors and Collaborators
J&M Shuler
Emory University
  More Information

No publications provided

Responsible Party: William Reisman, Emory University
ClinicalTrials.gov Identifier: NCT01077934     History of Changes
Other Study ID Numbers: 01-10-14b
Study First Received: February 24, 2010
Last Updated: October 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by J&M Shuler:
All Patients admitted to Grady Memorial Hospital with Unilateral Lower leg injury at risk for compartment syndrome

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

ClinicalTrials.gov processed this record on August 21, 2014