Clinical Trial: The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Trauma Patients
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Phase II The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Trauma Patients
Brief Summary: 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.
Detailed Summary:
Swelling builds up in a severely injured leg (for example, a broken leg). In up to 20% of very bad injuries, the swelling can be so great that it acts to cut off blood supply to the leg, strangulating it from the inside. When this occurs, it is called Acute Compartment Syndrome (ACS). This is a painful and bad situation, which needs to be diagnosed and then surgically treated in an urgent fashion. Currently, the standard way most physicians diagnose ACS is by clinical examination. By asking the patient questions, moving and inspecting the patient's leg and typically inserting a needle in the patient's legs to measure the amount of pressure in each leg. Physicians compile this information and make the final diagnosis. This method of diagnosis can be painful and requires measurements, sometimes invasive, to be made at points in time. ACS is a disease process that develops over time therefore someone may not have ACS at the time of examination, but may develop it several hours later. The treatment for ACS is called a fasciotomy. This treatment involves making a large incision from the knee to the ankle on each side of the lower leg.
The NIRS device has already been cleared by the FDA for detecting blood flow to the brain during anesthesia. NIRS may also be helpful in diagnosing ACS. Two of the primary advantages of this device are that it is noninvasive (not painful) and it collects data continuously, so that if the disease develops, it can be detected early and treated appropriately. In order to prove this, the device must first be tested by taking a series of measurements on people that are uninjured (control groups), those with serious leg injuries (investigational groups), and people in a critically injured state, but without leg injuries (critical controls).
The goal of this study is to collect the information necessary
Sponsor: U.S. Army Medical Research and Materiel Command
Current Primary Outcome: ACS [ Time Frame: 48 hours ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: U.S. Army Medical Research and Materiel Command
Dates:
Date Received: March 1, 2012
Date Started: February 2012
Date Completion: May 2017
Last Updated: November 7, 2016
Last Verified: December 2015
