院前使用的中暑降温设备:一项系统综述。
完整摘要 · 中文译文
目的:热射病和热衰竭(HS/HE)是危及生命的病症,需要立即干预。降温设备在急诊和院前救治中发挥着关键作用,但其有效性和现场适用性的报道并不一致。本系统综述评估了市售降温设备用于治疗HS/HE的效果,重点关注设备的可行性、性能以及用于院前和偏远地区部署的适宜性。 方法:于2025年8月/10月在学术数据库(PubMed、Scopus、Cochrane Library、Compendex、Engineering Village和IEEE Xplore)及通过Google Advanced Search获取的灰色文献中进行了全面的文献检索。学术记录使用Rayyan进行筛选,灰色文献则在自定义HTML抓取工具的辅助下用Excel进行整理。设备纳入标准为:符合美国食品药品监督管理局(FDA)对医疗器械的定义、设计用于成人、且专门针对HS/HE。提取的参数包括工作原理、降温速率、重量、尺寸、体积、电源要求、外部资源需求及可重复使用性。降温性能以McDermott等人报告的阈值作为基准进行评估,便携性则依据MIL-STD-1472H单人携带限值≤16kg进行评估。 结果:共识别并评估了18种设备。仅三种设备达到理想降温速率阈值(≥0.155°C/分钟),另有两种设备达到可接受性能(0.078-0.154°C/分钟)。约61%的设备未报告降 冷却率数据。五种设备符合现场便携性标准(≤16kg),但大多数因依赖水、电力或一次性组件而受到限制。仅有一种设备证明了远程使用的可行性;然而,该设备缺乏完全可重复使用性。 结论:尚无设备同时满足针对热射病/劳力型热射病(HS/HE)治疗的有效性、便携性、现场适用性和可重复使用性的综合标准。现行美国食品药品监督管理局(FDA)审批途径不要求报告关键性能指标,凸显了监管空白。需要开发适合现场条件的解决方案,并修订评估标准,优先考虑冷却性能、资源独立性和严苛环境下的可用性。
完整摘要 · 英文原文
OBJECTIVE: Heat stroke and heat exhaustion (HS/HE) are life-threatening conditions requiring immediate intervention. Cooling devices play a critical role in emergency and prehospital care, yet their effectiveness and field readiness are inconsistently reported. This systematic review evaluates commercially available cooling devices for the treatment of HS/HE with an emphasis on device feasibility, performance, and suitability for prehospital and remote deployment. METHODS: A comprehensive literature search was conducted in August/October 2025 across academic databases (PubMed, Scopus, Cochrane Library, Compendex, Engineering Village, and IEEE Xplore) and gray literature via Google Advanced Search. Academic records were screened using Rayyan, while gray literature was organized in Excel with the aid of a custom HTML scraper. Devices were included if they met the United States Food and Drug Administration (FDA) definition of a medical device, were designed for adult human use, and specifically addressed HS/HE. Parameters extracted included working principle, cooling rate, weight, dimensions, volume, power requirements, external resource demands, and reusability. Cooling performance was benchmarked using thresholds reported by McDermott, et al, and portability was assessed using the MIL-STD-1472H single-person carriage limit of ≤16kg. RESULTS: A total of 18 devices were identified and evaluated. Only three met the ideal cooling rate threshold (≥0.155°C/minute), and two others achieved acceptable performance (0.078-0.154°C/minute). Approximately 61% of devices did not report cooling rate data. Five devices met field portability criteria (≤16kg), though most were limited by reliance on water, power, or disposable components. Only one device demonstrated feasibility for remote use; this device, however, lacked full reusability. CONCLUSIONS: No device meets the combined criteria of effectiveness, portability, field readiness, and reusability for HS/HE treatment. Current FDA pathways do not require reporting of key performance metrics, highlighting a regulatory gap. There is a need for development of field-appropriate solutions and revised evaluation standards that prioritize cooling performance, resource independence, and usability in austere environments.