The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Trauma Patients (NIRS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- ACS [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 130 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated 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 |
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
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:
- No bony or vascular lower extremity injury (including femur or foot fractures)
- Admitted to the ICU for a traumatic injury (not a medical problem, such as a heart attack)
- 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| United States, Georgia | |
| Athens Regional Medical Center | Not yet recruiting |
| Athens, Georgia, United States, 30606 | |
| Contact: Mellisa Roskosky 706-433-4031 mellisa.nirs@gmail.com | |
| Principal Investigator: Charles Ogburn, MD | |
| Grady Memorial Hospital | Recruiting |
| Atlanta, Georgia, United States, 30303 | |
| Contact: Patty Bush 404-778-1563 patricia.a.bush@emory.edu | |
| Contact: Kendra Sanders 404-778-1563 ksandersamc@gmail.com | |
| Principal Investigator: William Reisman, MD | |
| Atlanta Medical Center | Recruiting |
| Atlanta, Georgia, United States, 30312 | |
| Contact: Patty Bush 404-778-1563 patricia.a.bush@emory.edu | |
| Contact: Kendra Sanders 404-778-1563 ksandersamc@gmail.com | |
| Principal Investigator: Bruce Ziran, MD | |
| 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: | May 15, 2013 |
| 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 May 21, 2013