Assessment of Near Infrared Spectroscopy as a Diagnostic Tool in Acute Compartment Syndrome
1 other identifier
observational
8
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2010
CompletedFirst Posted
Study publicly available on registry
March 1, 2010
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedApril 27, 2015
April 1, 2015
4 months
February 24, 2010
April 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
NIRS values in lower leg extremity injury
We will monitor patients during their hospital stay from the time of admission until discharge at likey day 4.
4 days
Study Arms (2)
Injured Extremity without compartment syndrome
Injured extremity with compartment syndrome
Interventions
Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.
Eligibility Criteria
All Patients admitted to Grady with Unilateral Lower leg injury at risk for compartment syndrome
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- J&M Shulerlead
- Emory Universitycollaborator
Study Sites (1)
Emory University
Atlanta, Georgia, 30303, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 24, 2010
First Posted
March 1, 2010
Study Start
November 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
April 27, 2015
Record last verified: 2015-04