The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome
1 other identifier
observational
120
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2011
2 active sites
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
July 27, 2010
CompletedFirst Posted
Study publicly available on registry
July 28, 2010
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJune 15, 2011
June 1, 2011
1.3 years
July 27, 2010
June 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of acute compartment syndrome (ACS)
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.
24-48 hours at study site
Secondary Outcomes (1)
Intracompartmental pressure (ICP)
24-48 hours at study site
Study Arms (2)
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
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.
Interventions
Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.
Eligibility Criteria
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.
You may qualify if:
- 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:
- Segemental tibia shaft fracture
- Comminuted tibia shaft fracture
- Schatzker Type III-VI tibial plateau fractures
- Mechanisms:
- Fall from a height of \>= 8 feet
- Motor vehicle or motorcycle crash
- Pedestrian versus automobile
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- J&M Shulerlead
- United States Department of Defensecollaborator
- Nonin Medicalcollaborator
Study Sites (2)
Atlanta Medical Center
Atlanta, Georgia, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brett Freedman, MD
Landstuhl Regional Medical Center
- PRINCIPAL INVESTIGATOR
William Reisman, MD
Emory University
- PRINCIPAL INVESTIGATOR
Bruce Ziran, MD
Atlanta Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 27, 2010
First Posted
July 28, 2010
Study Start
September 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
June 15, 2011
Record last verified: 2011-06