Pardo Anat, Nahum Fridland Shir, Rak Or Lee, Klochendler Frishman Emilie, Zafrir Danieli Hadar, Shmueli Anat, Barbash-Hazan Shiri, Wiznitzer Arnon, Walfisch Asnat, Sela Tomer, Wolff Leor, Hadar Eran
Rabin Medical Center, Helen Schneider Hospital for Women, Petach Tikva, Israel.
Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel.
Am J Perinatol. 2025 Jul;42(9):1192-1199. doi: 10.1055/a-2469-0887. Epub 2024 Nov 19.
Pulsenmore ES is a self-scanning ultrasound (US) system for remote fetal assessment. It comprises a handheld transducer that serves as a smartphone cradle coupled with an application and clinician's web-viewer dashboard. Recently, a novel capability was added to the system allowing offline fetal heart rate (FHR) and maximal vertical pocket (MVP) measurements. The aim of this study was to evaluate these tools for usability and accuracy.A prospective, non-randomized, non-blinded clinical study design was used. Pulsenmore ES scans were obtained by non-professional laypersons in app-guided (AG) mode (user follows video tutorials in the application) or clinician-guided (CG) mode (user is guided by a health care professional in a real-time telemedicine visit). The scans were stored on a cloud for later interpretation by a health care professional. Each self-scan was immediately followed by a standard US scan performed by a clinician. The asynchronous FHR and MVP measurements made on the AG and CG scans through the designated dashboard were analyzed and compared with the real-time, in-clinic (INC) measurements.The cohort included 28 women. Rates of successful utilization of the Pulsenmore tool for measurement of FHR were 84.7 ± 11.24% of scans made in AG mode and 96.3 ± 6.35% of scans made in CG mode. Corresponding values for MVP were 91.7 ± 2.31% and 95.0 ± 1.73%. FHR accuracy (difference from INC values) was 10.8 ± 7.5 beats per minute (bpm; 7.2%) in AG mode and 5.8 ± 5.1 bpm (4%) in CG mode. MVP accuracy was 1.3 ± 1.4 cm (22%) and 0.9 ± 0.8 cm (14%), respectively. Sensitivity (87.5% and 100% in AG and CG modes, respectively) and specificity (95% and 95.5% in AG and CG modes, respectively) were established for MVP.FHR and MVP measurements obtained from scans captured by the self-operated Pulsenmore ES ultrasound platform are highly accurate and reliable for clinical use relative to standard INC measurements. · Pulsenmore ES is a self-scanning US system for remote fetal assessment.. · FHR and MVP can be accurately and remotely measured from home.. · Home US can play a critical role in remote antenatal surveillance..
Pulsenmore ES是一款用于远程胎儿评估的自扫描超声(US)系统。它包括一个手持换能器,该换能器充当与应用程序和临床医生网络查看器仪表板相连的智能手机支架。最近,该系统增加了一项新功能,允许进行离线胎儿心率(FHR)和最大垂直羊水池深度(MVP)测量。本研究的目的是评估这些工具的可用性和准确性。
采用前瞻性、非随机、非盲法的临床研究设计。非专业外行人以应用程序引导(AG)模式(用户按照应用程序中的视频教程操作)或临床医生引导(CG)模式(用户在实时远程医疗就诊中由医疗保健专业人员指导)获得Pulsenmore ES扫描图像。扫描图像存储在云端,以供医疗保健专业人员稍后解读。每次自扫描后,紧接着由临床医生进行标准超声扫描。通过指定仪表板对AG和CG扫描图像上进行的异步FHR和MVP测量进行分析,并与临床实时(INC)测量结果进行比较。
该队列包括28名女性。在AG模式下进行的扫描中,Pulsenmore工具成功用于测量FHR的比例为84.7±11.24%,在CG模式下进行的扫描中这一比例为96.3±6.35%。MVP的相应值分别为91.7±2.31%和95.0±1.73%。AG模式下FHR的准确性(与INC值的差异)为每分钟10.8±7.5次心跳(bpm;7.2%),CG模式下为5.8±5.1 bpm(4%)。MVP的准确性分别为1.3±1.4 cm(22%)和0.9±0.8 cm(14%)。针对MVP确定了敏感性(AG和CG模式下分别为87.5%和100%)和特异性(AG和CG模式下分别为95%和95.5%)。
相对于标准INC测量,通过自行操作的Pulsenmore ES超声平台捕获的扫描图像获得的FHR和MVP测量结果在临床应用中具有高度准确性和可靠性。· Pulsenmore ES是用于远程胎儿评估的自扫描超声系统。· 可以在家中准确且远程地测量FHR和MVP。· 家用超声在远程产前监测中可发挥关键作用。