Prospective Comparison of Handheld Ultrasound Devices from Different Manufacturers with Respect to B-Scan Quality and Clinical Significance for Various Abdominal Sonography Questions

Abstract

Background: Handheld ultrasound (HHUS) devices have chiefly been deployed in emergency medicine, where they are considered a valid tool. The data situation is less clear in the case of internal questions in abdominal sonography. In our study, we investigate whether HHUS devices from different manufacturers differ in their B-scan quality, and whether any differences are relevant for the significance of an internal ultrasound examination. Method: The study incorporated eight HHUS devices from different manufacturers. Ultrasound videos of seven defined sonographic questions were recorded with all of the devices. The analogue recording of the same findings with a conventional high-end ultrasound (HEUS) device served as an evaluation criterion. Then, the corresponding findings were played side by side and evaluated by fourteen ultrasound experts using a point scale (5 points = very good; 1 point = insufficient). Results: The HHUS devices achieved relatively good results in terms of both the B-scan quality assessment and the ability to answer the clinical question, regardless of the manufacturer. One of the tested HHUS devices even achieved a significantly (p < 0.05) higher average points score in both the evaluation of B-scan quality and in the evaluation of clinical significance than the other devices. Regardless of the manufacturer, the HHUS devices performed best when determining the status/inferior vena cava volume and in the representation of ascites/free fluid. Conclusion: In various clinical abdominal sonography questions, HHUS systems can reliably reproduce findings, and are—while bearing their limitations in mind—an acceptable alternative to conventional HEUS systems. Irrespective of this, the present study demonstrated relevant differences in the B-scan quality of HHUS devices from different manufacturers.

Inter-System Variability of Eight Different Handheld Ultrasound (HHUS) Devices—A Prospective Comparison of B-Scan Quality and Clinical Significance in Intensive Care

“…This prospective clinical non-inferiority study compares 8 HHUS devices from different manufacturers under real-life clinical circumstances, with regard to their B-image quality for use in the intensive care setting. A simultaneously used HEUS system serves as a reference, in accordance with previous studies [27,28] The primary endpoint of the study is defined as the rating of B-image quality, using a 5-point Likert scale (5 points = very good; 1 point = insufficient). Secondary endpoints relate to the ability to address previously defined clinical questions.…”

“…The study schedule and the applied methodology are shown schematically in Figure 1, in accordance with [27,28] Referring to the number E-01-20220502, the study was approved by the ethics committee of the Medical University Theodor Fontane Brandenburg. Written agreement was given by all participating patients, including the usage of all sonographic findings, in accordance with the study protocol.…”

“…The study schedule and the applied methodology are shown schematically in Figure 1, in accordance with [27,28] Figure 1. Illustration of the study design, including measurement time points, in accordance with [27,28].…”

“…The study schedule and the applied methodology are shown schematically in Figure 1, in accordance with [27,28] Figure 1. Illustration of the study design, including measurement time points, in accordance with [27,28]. From July 2022 to November 2022, a total of 8 HHUS devices from various manufacturers were employed in clinical settings.…”

“…In an online interview, both ultrasound clips were played simultaneously (for an example, see Figure 2). Sample question of the online interview with two sonography videos to be played in parallel (HHUS and HEUS), to be evaluated by the participating ultrasound experts using two rating scales with regard to sonographic image quality and clinical significance, in accordance with [27,28]. Sample question of the online interview with two sonography videos to be played in parallel (HHUS and HEUS), to be evaluated by the participating ultrasound experts using two rating scales with regard to sonographic image quality and clinical significance, in accordance with [27,28].…”