Model Acute Compartment Syndrome Study

描述（由申请人提供）：在该II期SBIR中，Luna Innovations将对EN-TACT（tm）患者监测器进行人体受试者测试，以确定与肌内压力（IMP）的缝道导管测量（目前的金标准测量）相比，诊断筋膜间室综合征的敏感性和特异性。据Ulmer（2002）报道，一期动物模型显示，EN-TACT（tm）患者监护仪比临床体征诊断的敏感性高得多（73%对13-19%），特异性相当（93%对97%）。该II期SBIR的目标是提高人体受试者测试的诊断准确性。为了实现这一目标，第二阶段研究的三个具体目标是：(1)通过消除操作员在探头放置和解释哪个超声回波对应于哪个解剖特征方面的依赖变化，减少组织位移信号的个体差异。(2)利用小腿和腹部的模型室综合征建立对人类受试者的诊断效用。(3)在加州大学圣地亚哥分校医学院、东弗吉尼亚医学院、新墨西哥大学医学院和威廉玛丽学院运动医学系的临床试验中验证诊断的实用性。

DESCRIPTION (provided by applicant): In this Phase II SBIR Luna Innovations will perform human subject tests of the EN-TACT(tm) Patient Monitor to determine the sensitivity and specificity of diagnosis of compartment syndrome as compared to slit-catheter measurements of intramuscular pressure (IMP), the current gold standard measurement. A Phase I animal model showed that the EN-TACT(tm) Patient Monitor is substantially more sensitive than diagnosis by clinical signs (73% vs. 13-19%) with comparable specificity (93% vs. 97%), as reported by Ulmer (2002). The objective of this Phase II SBIR is to improve the diagnostic accuracy in human subject tests. To achieve this objective, three specific aims for the Phase II research are: (1) Reduce subject-to-subject variability in tissue displacement signal by eliminating operator dependant variations in probe placement and interpretation of which ultrasonic echo corresponds to which anatomical feature. (2) Establish diagnostic utility in human subjects using model compartment syndromes of the lower leg and abdomen. (3) Verify diagnostic utility in clinical tests at the UCSD School of Medicine, Eastern Virginia Medical School, the University of New Mexico School of Medicine and the College of William and Mary Sports Medicine Department. PUBLIC HEALTH RELEVANCE: There is a great need for improved diagnosis of compartment syndrome, as inaccuracy in the current methods of diagnosis often lead to delays in treatment. Missed diagnosis of compartment syndrome to be one of the most common causes of litigation against doctors in North America, with the average malpractice award from a missed compartment syndrome case approximately $280,000 in 1993. In the absence of good diagnostic tools for compartment syndrome, anecdotal evidence suggests that the fasciotomy - a surgical opening of the muscle fascia to release compartment pressures - is often performed prophylactically, subjecting the patient to a long and expensive recovery that might otherwise be avoided.