- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01077934
Assessment of Near Infrared Spectroscopy as a Diagnostic Tool in Acute Compartment Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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."
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30303
- Emory University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Injured Extremity without compartment syndrome
|
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
|
Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NIRS values in lower leg extremity injury
Time Frame: 4 days
|
We will monitor patients during their hospital stay from the time of admission until discharge at likey day 4.
|
4 days
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01-10-14b
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Compartment Syndrome
-
University of Wisconsin, MadisonTerminatedCompartment Syndrome of LegUnited States
-
U.S. Army Medical Research and Development CommandUnknownAnterior Tibial Compartment SyndromeUnited States
-
Emory UniversityIpsenSuspendedCompartment Syndrome of LegUnited States
-
University of Wisconsin, MadisonSuspendedCompartment Syndrome of LegUnited States
-
Dartmouth-Hitchcock Medical CenterDartmouth CollegeRecruitingCompartment Syndromes | Compartment Syndrome of Forearm | Compartment Syndrome of Lower LegUnited States
-
MY01 Inc.Nova Scotia Health AuthorityCompletedCompartment Syndrome Traumatic Lower Extremity | Compartment Syndrome Traumatic Upper ExtremityCanada
-
Bispebjerg HospitalRecruitingCompartment Syndrome Nontraumatic Lower LegDenmark
-
Major Extremity Trauma Research ConsortiumNot yet recruiting
-
MY01 Inc.McGill University Health Centre/Research Institute of the McGill University... and other collaboratorsCompletedAcute Compartment SyndromeCanada
-
J&M ShulerNonin Medical, IncCompletedAcute Compartment SyndromeUnited States
Clinical Trials on near-infrared spectroscopy
-
University of California, IrvineBeckman Laser Institute University of California Irvine; Brooke Army Medical...CompletedHemorrhagic ShockUnited States
-
Zekai Tahir Burak Women's Health Research and Education...UnknownAnemic Preterms, Cerebral Oxygenation,Somatic Oxygenation,Blood TransfusionTurkey
-
Tel-Aviv Sourasky Medical CenterNot yet recruiting
-
National Cerebral and Cardiovascular CenterRecruiting
-
Chinese University of Hong KongNot yet recruitingTraumatic Brain Injury | Intracerebral HemorrhageHong Kong
-
Medical College of WisconsinMarquette UniversityRecruitingEpilepsies, PartialUnited States
-
University of Kansas Medical CenterCompleted
-
Queen's UniversityCompletedSepsis | Delirium | Critical Illness | Respiratory FailureCanada
-
Bursa Yüksek İhtisas Education and Research HospitalNot yet recruitingNerve Block | Near Infrared Spectroscopy | Lumbar Plexus
-
University Children's Hospital, ZurichNot yet recruitingAbdominal Compartment Syndrome | Intraabdominal HypertensionSwitzerland