一种新的连续室压监测辅助诊断急性室室综合征的临床试验。

IF 1.6 3区 医学 Q3 ORTHOPEDICS
Mohammed Ali Balhareth, Kate Vaile, Prism Schneider, Allan Liew, Jeremy Hall, Pierre Guy, Abdel-Rahman Lawendy, Job Doornberg, Ruurd Jaarsma, Ross Leighton
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引用次数: 0

摘要

目的:评价一种新的可报告连续压力的室压监测仪及其对急性室室综合征(ACS)诊断的贡献。方法:设计:多中心、非随机、前瞻性研究。环境:六个一级创伤中心。患者选择标准:入选的是急性长骨骨折患者(OTA 11-13、2R、2U、31-33和41-43),在术前或术后将微机电传感器(MEMS)装置插入外科医生认为最有可能发生ACS的椎间室。连续测量室内压(ICP)长达18小时(根据FDA和加拿大卫生部的指示);同时评估典型室间室综合征的临床体征。结果测量和比较:主要测量结果是设备在所有参与地点的易用性、准确性和安全性。通过外科医生完成的调查来评估易用性,这些调查评估了他们对设备功能和可用性的信心。准确性是通过分析患者结果来确定的,以手术结果和临床分辨率为金标准,评估设备的结果是否对应于室室综合征的真阳性和真阴性病例。可行性定义为设备能够融入临床工作流程,在典型条件下可靠运行,并为ACS诊断提供可操作数据的能力。次要结果包括连续室内压(ICP)测量及其诊断价值。通过比较连续ICP数据与基于“6p”(疼痛、苍白、感觉异常、无脉、变温和麻痹)的临床评估来评估敏感性和特异性,以确定它们在诊断ACS中的综合效用。结果:共纳入100例患者,其中男性68例,女性32例,平均年龄42岁(17-80岁)。所有患者均发生骨折,25例胫骨近端(OTA/AO-41), 40例胫骨中轴(OTA/AO42), 13例胫骨远端(OTA/AO43), 11例前臂(OTA/ ao2r . 2u), 6例股骨(OTA/AO31-33), 5例肱骨(OTA/ ao11 -13)。89例患者术后采用MEMS装置,11例患者术前采用MEMS装置。93%的参与调查的外科医生表示对该设备的功能和易用性很有信心。平均测量压力16h36 (3h-18h)。无并发症报道。术后ICPs (25.4 mmHg)高于术前ICPs (18.9 mmHg) (p =0.0462)。未发生隔室综合征的患者术后压力在4小时后呈下降趋势(23.8mmHg)。使用患者结果作为诊断准确性的金标准,对单独的ICP、单独的P、单独的压力趋势或三个指标的组合进行敏感性和特异性分析。连续监测压力测量曲线的趋势比单一的绝对压力值更可靠,有助于正确诊断偏离标准ACS诊断文献的ACS。MEMS装置可使ACS的诊断提前4小时。当连续压力测量与标准临床检查相结合时,灵敏度和特异性均达到100%。结论:基于mems的装置可靠地实现了所有研究机构的连续室压监测。进一步检查连续趋势和伴随的灌注压可以使外科医生作为临床辅助诊断ACS比单独的临床症状早许多小时。证据等级:II级——前瞻性研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Clinical trial of a new continuous compartment pressure monitoring to aid in the diagnosis of Acute Compartment Syndrome.

Objectives: To evaluate a new compartment pressure monitor reporting continuous pressures and its contribution to Acute Compartment Syndrome (ACS) diagnosis.

Methods: Design: Multicenter, non-randomized, prospective study.

Setting: Six Level-I Trauma Centers.

Patient selection criteria: Enrolled were patients with acute long bone fractures (OTA 11-13, 2R, 2U, 31-33, and 41-43) where the Micro Electric Mechanical Sensor (MEMS) device was inserted either pre- or post-operatively into the compartment most likely to develop ACS, as deemed by the surgeon. Intracompartmental pressures (ICP) were continuously measured for up to 18 hours (as indicated by the FDA and Health Canada); clinical signs were simultaneously assessed for canonical compartment syndrome signs.

Outcome measures and comparisons: The primary measurement outcomes were ease of use, accuracy, and safety of the device across all participating sites. Ease of use was assessed through surveys completed by surgeons, which evaluated their confidence in the device's functionality and usability. Accuracy was determined by analyzing patient outcomes, using surgical findings and clinical resolution as the gold standards, to assess whether the device's results corresponded to true positive and true negative cases of compartment syndrome. Feasibility was defined as the device's ability to integrate into the clinical workflow, operate reliably under typical conditions, and provide actionable data for ACS diagnosis. The secondary outcomes included continuous intracompartmental pressure (ICP) measurements and their diagnostic value. Sensitivity and specificity were evaluated by comparing continuous ICP data with clinical assessments based on the "6 P's" (pain, pallor, paresthesia, pulselessness, poikilothermia, and paralysis) to determine their combined utility in diagnosing ACS.

Results: A total of 100 patients, 68 males and 32 females with an average age of 42 years old (17-80 years old), were enrolled. All of the patients had suffered a fracture, 25 proximal tibias (OTA/AO-41), 40 midshaft tibias (OTA/AO42), 13 distal tibias (OTA/AO43), 11 forearms (OTA/AO 2R.2U), 6 femurs (OTA/AO31-33), 5 humerus (OTA/AO 11-13). Eighty-nine patients received the MEMS device post-operatively and 11 patients pre-operatively. 93% of participating surgeons reported confidence in the device's function and ease of use. Pressures were measured on average for 16h36 (3h-18h). No complications were reported. Post-operative ICPs (25.4 mmHg) were higher (p =0.0462) on average than pre-operative ICPs (18.9 mmHg). Patients that did not develop Compartment Syndrome had their post-operative pressures trend down after 4 hours (23.8mmHg). Sensitivity and specificity analyses of ICP alone, delta P alone, pressure trends alone, or a combination of the three metrics were conducted using patient outcomes as the gold standard for diagnostic accuracy. The trend of the curve in continuous monitoring pressure measurements proved more reliable than a single absolute pressure value in aiding in the correct diagnosis of ACS deviating from standard ACS diagnosis literature The MEMS device allowed earlier diagnosis of ACS by 4 hours (. When continuous pressure measurement was combined with standard clinical examination, the sensitivity and specificity reached 100%.

Conclusions: The MEMS-based device reliably enabled continuous compartment pressure monitoring in all the study institutions. Further examination of continuous trends and accompanying perfusion pressure could allow surgeons the clinical adjunct to diagnose ACS many hours earlier than clinical signs alone.

Level of evidence: Level II - Prospective study.

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来源期刊
Journal of Orthopaedic Trauma
Journal of Orthopaedic Trauma 医学-运动科学
CiteScore
3.90
自引率
8.70%
发文量
396
审稿时长
3-8 weeks
期刊介绍: Journal of Orthopaedic Trauma is devoted exclusively to the diagnosis and management of hard and soft tissue trauma, including injuries to bone, muscle, ligament, and tendons, as well as spinal cord injuries. Under the guidance of a distinguished international board of editors, the journal provides the most current information on diagnostic techniques, new and improved surgical instruments and procedures, surgical implants and prosthetic devices, bioplastics and biometals; and physical therapy and rehabilitation.
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