Model Acute Compartment Syndrome Study

描述（由申请人提供）：在本II期研究中，SBIR Luna Innovations将对EN-TACT（tm）患者监护仪进行人体受试者测试，以确定与肌内压（IMP）的狭缝导管测量（当前的金标准测量）相比，诊断筋膜室综合征的灵敏度和特异性。I期动物模型显示，EN-TACT（tm）患者监护仪的灵敏度明显高于临床体征诊断（73% vs. 13-19%），特异性相当（93% vs. 97%），如Ulmer（2002）所报告。该II期SBIR的目的是提高人类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）通过消除探头放置和解释哪个超声回波对应于哪个解剖特征的操作员依赖性变化，减少组织位移信号中的受试者与受试者之间的差异。(2)使用小腿和腹部的模型筋膜室综合征建立人类受试者的诊断效用。(3)在UCSD医学院、东弗吉尼亚医学院、新墨西哥州医学院和威廉和玛丽学院运动医学系的临床试验中验证诊断实用性。 公共卫生相关性：由于目前诊断方法的不准确常常导致治疗的延误，因此非常需要改进骨筋膜室综合征的诊断。筋膜室综合征的漏诊是北美对医生提起诉讼的最常见原因之一，1993年漏诊筋膜室综合征病例的平均医疗事故赔偿额约为280 000美元。由于缺乏良好的诊断工具，筋膜室综合征，轶事证据表明，筋膜切开术-肌肉筋膜的手术开放，以释放筋膜室压力-往往是执行的替代品，使患者遭受长期和昂贵的恢复，否则可能会避免。

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.