Montemerani Sara, Fabrizi Cosimo, Sacchi Cecilia, Belperio Antoine, Moriani Lorenzo, Pacchi Samuele, Garofalo Cinzia, Sbrana Giovanni, Venezia Duccio, Zanobetti Maurizio, Nocentini Simone
UOC Medicina d'Emergenza Urgenza e Pronto Soccorso Ospedale San Donato, Dipartimento Emergenza Urgenza, Azienda USL Toscana Sud Est, Arezzo, Italia.
Scuola di specializzazione in Medicina d'Emergenza Urgenza, Università degli Studi di Siena, Siena, Italia.
Open Access Emerg Med. 2024 Dec 6;16:313-321. doi: 10.2147/OAEM.S475328. eCollection 2024.
Mild Traumatic brain injury is classified based on Glasgow Coma Scale (GCS 13-15), it also involves transient alteration of brain function, which may lead to severe short- and long-term sequelae. When treating a patient with a mild head injury outside the hospital, it is of crucial importance to decide whether to transport him to a center without neurosurgery or to a center equipped with neurosurgery (primary centralization). Recent decades have seen exploration of portable, non-invasive devices for intracranial injury and stroke detection, with microwave frequency electromagnetic field technology showing promising clinical outcomes. This clinical investigation aims to assess the diagnostic accuracy of the TES HT100 medical device, utilizing electromagnetic fields for endocranial lesion screening.
Patients with mild traumatic brain injury were randomly enrolled according to inclusion criteria. Twenty-three patients recruited from the Intensive Short-Term Observation (ISTO) unit at San Donato Hospital in Arezzo. The sensitivity and specificity of the TES HT were evaluated statistically against cranial computed tomography (CT), the gold standard.
A preliminary analysis shows a sensitivity of 100% and a specificity of 100%. Based on these results, there is maximum concordance between the two examinations, and the AUC is 1. No adverse events related to the use of TES HT100 or the examination.
The device's ability to differentiate patients with intracranial lesions from those without can streamline the diagnostic and therapeutic process, potentially leading to improved patient outcomes. If Temnography will maintain high standards of sensitivity and specificity with the expansion of the enrolled population, it could be considered as a stable screening tool in the Emergency Room (ER). We could think to apply this technology to reduce the length of stay that patients with mTBI have to spend in ER for observation. Temnography could also be useful in special categories of patients such as pregnant women or the pediatric population. Moreover, another front of future development of this technology could be extending the study to include Territorial Emergency. In this context, Temnography could aid centralized decision-making in patient care.
轻度创伤性脑损伤根据格拉斯哥昏迷量表(GCS 13 - 15)进行分类,它还涉及脑功能的短暂改变,这可能导致严重的短期和长期后遗症。在医院外治疗轻度头部受伤患者时,决定将其转运至无神经外科的中心还是配备神经外科的中心(初次集中化)至关重要。近几十年来,人们一直在探索用于颅内损伤和中风检测的便携式非侵入性设备,微波频率电磁场技术显示出有前景的临床结果。这项临床研究旨在评估TES HT100医疗设备利用电磁场进行颅内病变筛查的诊断准确性。
根据纳入标准随机招募轻度创伤性脑损伤患者。从阿雷佐圣多纳托医院的强化短期观察(ISTO)单元招募了23名患者。将TES HT的敏感性和特异性与金标准头颅计算机断层扫描(CT)进行统计学评估。
初步分析显示敏感性为100%,特异性为100%。基于这些结果,两项检查之间存在最大一致性,曲线下面积为1。未发生与使用TES HT100或检查相关的不良事件。
该设备区分有颅内病变患者和无颅内病变患者的能力可以简化诊断和治疗过程,有可能改善患者预后。如果随着纳入人群的扩大,脑断层扫描术能保持高敏感性和特异性标准,它可被视为急诊室(ER)的一种稳定筛查工具。我们可以考虑应用这项技术来缩短轻度创伤性脑损伤患者在急诊室观察的停留时间。脑断层扫描术在孕妇或儿科人群等特殊患者类别中也可能有用。此外,这项技术未来发展的另一个方向可能是将研究扩展到包括区域急诊。在这种情况下,脑断层扫描术可有助于患者护理中的集中决策。