Diagnostic accuracy of pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalized: a prospective diagnostic cohort study

Sara Monteiro, Teresa Tavares, Luís Salazar, Filipa Coelho, João Carvalho, Telma Barbosa, Maria G. Reis, Lurdes Morais, Ana Ramos, Manuel Ferreira-Magalhães
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Abstract

Background: Pneumonia, the leading infectious cause of death in children worldwide, often requires a chest radiograph (CXR) for diagnosis, involving radiation exposure. Point-of-Care Ultrasound (POCUS) offers a radiation-free alternative and, specifically the pocket-size variant, enhances convenience at the patient's bedside. While evidence supports ultrasound's accuracy in detecting community-acquired pneumonia (CAP) in children comparable to CXR, few studies have explored its ability to distinguish pneumonia etiology, especially utilizing pocket-size POCUS devices. Methods: In this prospective diagnostic cohort study conducted over a year in a tertiary pediatric referral center, we aim to assess the diagnostic accuracy of a pocket-size POCUS device compared to CXR for determining the etiology of CAP in pediatric patients (aged >6 months and <18 years). At least 76 participants diagnosed with CAP will undergo independent POCUS examinations at various intervals, complemented by CXRs when necessary, independently classified by a third investigator. The General Electrics Vscan AirTM®, featuring Bluetooth connectivity to smartphone/tablet, will be employed for POCUS. Data collection will include systematized POCUS and CXR descriptions, alongside sociodemographic, clinical, and therapeutic variables. Statistical analysis using SPSS® version 28 will evaluate the diagnostic accuracy of the POCUS device. Conclusions: This trial's outcomes hold significant promise in unveiling unknown data about the diagnostic accuracy of pocket-size POCUS for pediatric CAP etiological diagnosis. Utilizing a device meeting technical recommendations, featuring a dual-headed probe and Bluetooth connectivity, this study has the potential to bring innovation to clinical practice, improving patient care and creating scientific value. Trial Registration Number: NCT06296693.
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前瞻性队列诊断研究:袖珍肺部超声波在确定住院儿童肺炎病因和监测并发症方面的诊断准确性
背景:肺炎是导致全球儿童死亡的主要传染病因,通常需要进行胸部 X 光检查 (CXR) 来诊断,这涉及到辐射暴露。护理点超声波(POCUS)提供了一种无辐射的替代方法,尤其是袖珍型超声波,更方便病人在床边进行诊断。虽然有证据表明超声波在检测儿童社区获得性肺炎(CAP)方面的准确性可与 CXR 相媲美,但很少有研究探讨其区分肺炎病因的能力,尤其是利用袖珍型 POCUS 设备:这项前瞻性诊断队列研究在一家三级儿科转诊中心进行,为期一年,目的是评估袖珍型 POCUS 设备与 CXR 相比在确定儿科患者(年龄大于 6 个月且小于 18 岁)CAP 病因方面的诊断准确性。至少 76 名确诊为 CAP 的参与者将在不同时间段接受独立的 POCUS 检查,必要时辅以 CXR,并由第三名研究人员进行独立分类。将使用通用电气公司的 Vscan AirTM® 进行 POCUS 检查,该设备具有与智能手机/平板电脑蓝牙连接的功能。数据收集将包括系统化的 POCUS 和 CXR 描述,以及社会人口学、临床和治疗变量。使用 SPSS® 28 版进行的统计分析将评估 POCUS 设备的诊断准确性:该试验的结果有望揭示袖珍型 POCUS 用于小儿 CAP 病因诊断准确性的未知数据。这项研究利用符合技术建议的设备、双头探头和蓝牙连接,有可能为临床实践带来创新,改善患者护理并创造科学价值:NCT06296693.
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