On the design and development of a handheld electrocardiogram device in a clinical setting.

Cardiovascular diseases (CVDs) are a global burden that requires attention. For the detection and diagnosis of CVDs, the 12-lead ECG is a key tool. With technological advancements, ECG devices are becoming smaller and available for home use. Most of these devices contain a limited number of leads and are aimed to detect atrial fibrillation (AF). To investigate whether a four-electrode arrangement could provide enough information to diagnose other CVDs, further research is necessary. At the University Medical Center Utrecht in a multidisciplinary team, we developed the miniECG, a four-electrode ECG handheld system for scientific research in clinical environments (TRL6). This paper describes the process followed during the development of the miniECG. From assembling a multidisciplinary team, which includes engineers, cardiologists, and clinical physicians to the contribution of team members in the design input, design, and testing for safety and functionality of the device. Finally, we detail how the development process was composed by iterative design steps based on user input and intended use evolution. The miniECG is a device compliant for scientific research with patients within Dutch Medical Centers. We believe that hospital-based development led to a streamlined process, which could be applied for the design and development of other technologies used for scientific research in clinical environments.

Detection of acute coronary occlusion with a novel mobile electrocardiogram device: a pilot study.

Aims: Many portable electrocardiogram (ECG) devices have been developed to monitor patients at home, but the majority of these devices are single lead and only intended for rhythm disorders. We developed the miniECG, a smartphone-sized portable device with four dry electrodes capable of recording a high-quality multi-lead ECG by placing the device on the chest. The aim of our study was to investigate the ability of the miniECG to detect occlusive myocardial infarction (OMI) in patients with chest pain. Methods and results: Patients presenting with acute chest pain at the emergency department of the University Medical Center Utrecht or Meander Medical Center, between May 2021 and February 2022, were included in the study. The clinical 12-lead ECG and the miniECG before coronary intervention were recorded. The recordings were evaluated by cardiologists and compared the outcome of the coronary angiography, if performed. A total of 369 patients were measured with the miniECG, 46 of whom had OMI. The miniECG detected OMI with a sensitivity and specificity of 65 and 92%, compared with 83 and 90% for the 12-lead ECG. Sensitivity of the miniECG was similar for different culprit vessels. Conclusion: The miniECG can record a multi-lead ECG and rule-in ST-segment deviation in patients with occluded or near-occluded coronary arteries from different culprit vessels without many false alarms. Further research is required to add automated analysis to the recordings and to show feasibility to use the miniECG by patients at home.

Detection of Ischemic ST-Segment Changes Using a Novel Handheld ECG Device in a Porcine Model.

Background: Portable, smartphone-sized electrocardiography (ECG) has the potential to reduce time to treatment for patients suffering acute cardiac ischemia, thereby lowering the morbidity and mortality. In the UMC Utrecht, a portable, smartphone-sized, multi-lead precordial ECG recording device (miniECG 1.0, UMC Utrecht) was developed. Objectives: The purpose of this study was to investigate the ability of the miniECG to capture ischemic ECG changes in a porcine coronary occlusion model. Methods: In 8 animals, antero-septal myocardial infarction was induced by 75-minute occlusion of the left anterior descending artery, after the first or second diagonal. MiniECG and 12-lead ECG recordings were acquired simultaneously before, during and after coronary artery occlusion and ST-segment deviation was evaluated. Results: During the complete occlusion and reperfusion period, miniECG showed large ST-segment deviation in comparison to 12-lead ECG. MiniECG ST-segment deviation was observed within 1 minute for most animals. The miniECG was positive for ischemia (ie, ST-segment deviation ≥1 mm) for 99.7% (Q1-Q3: 99.6%-99.9%) of the occlusion time, while the 12-lead was only positive for 79.8% (Q1-Q3: 81.1%-98.7%) of the time (P = 0.018). ST-segment deviation reached maxima of 10.5 mm [95% CI: 6.5-14.5 mm] vs 5.0 mm [95% CI: 2.0-8.0 mm] for the miniECG vs 12-lead ECG, respectively. Conclusions: MiniECG ST-segment deviation was observed early and was of large magnitude during 75 minutes of porcine transmural antero-septal infarction. The miniECG was positive for ischemia for the complete occlusion period. These findings demonstrate the potential of the miniECG in the detection of cardiac ischemia. Although clinical research is required, data suggests that the miniECG is a promising tool for the detection of cardiac ischemia.

Development process of a mobile electronic medical record for nurses: a single case study.

BACKGROUND: With the growing shortage of nurses, labor-saving technology has become more important. In health care practice, however, the fit with innovations is not easy. The aim of this study is to analyze the development of a mobile input device for electronic medical records (MEMR), a potentially labor-saving application supported by nurses, that failed to meet the needs of nurses after development. METHOD: In a case study, we used an axiomatic design framework as an evaluation tool to visualize the mismatches between customer needs and the design parameters of the MEMR, and trace these mismatches back to (preliminary) decisions in the development process. We applied a mixed-method research design that consisted of analyzing of 118 external and internal files and working documents, 29 interviews and shorter inquiries, a user test, and an observation of use. By factoring and grouping the findings, we analyzed the relevant categories of mismatches. RESULTS: The involvement of nurses during the development was extensive, but not all feedback was, or could not be, used effectively to improve the MEMR. The mismatches with the most impact were found to be: (1) suboptimal supportive technology, (2) limited functionality of the app and input device, and (3) disruption of nurses' workflow. Most mismatches were known by the IT department when the MEMR was offered to the units as a product. Development of the MEMR came to a halt because of limited use. CONCLUSION: Choices for design parameters, made during the development of labor-saving technology for nurses, may conflict with the customer needs of nurses. Even though the causes of mismatches were mentioned by the IT department, the nurse managers acquired the MEMR based on the idea behind the app. The effects of the chosen design parameters should not only be compared to the customer needs, but also be assessed with nurses and nurse managers for the expected effect on the workflow.

Implementing Medical Technological Equipment in the OR: Factors for Successful Implementations.

Operating rooms (ORs) more and more evolve into high-tech environments with increasing pressure on finances, logistics, and a not be neglected impact on patient safety. Safe and cost-effective implementation of technological equipment in ORs is notoriously difficult to manage, specifically as generic implementation activities omit as hospitals have implemented local policies for implementations of technological equipment. The purpose of this study is to identify success factors for effective implementations of new technologies and technological equipment in ORs, based on a systematic literature review. We accessed ten databases and reviewed included articles. The search resulted in 1592 titles for review, and finally 37 articles were included in this review. We distinguish influencing factors and resulting factors based on the outcomes of this research. Six main categories of influencing factors on successful implementations of medical equipment in ORs were identified: "processes and activities," "staff," "communication," "project management," "technology," and "training." We identified a seventh category "performance" referring to resulting factors during implementations. We argue that aligning the identified influencing factors during implementation impacts the success, adaptation, and safe use of new technological equipment in the OR and thus the outcome of an implementation. The identified categories in literature are considered to be a baseline, to identify factors as elements of a generic holistic implementation model or protocol for new technological equipment in ORs.

The use of near-infrared light for safe and effective visualization of subsurface blood vessels to facilitate blood withdrawal in children.

Obtaining access to blood vessels can be difficult, especially in children. Visualization of subsurface blood vessels might be a solution. Ultrasound and visible light have been used to this purpose, but have some drawbacks. Near-infrared light might be a better option since subsurface blood vessels can be visualized in high contrast due to less absorption and scattering in tissue as compared to visible light. Our findings with a multispectral imaging system support this theory. A device, the VascuLuminator, was developed, based on transillumination of the puncture site with near-infrared light. The VascuLuminator was designed to meet the requirements of compact and safe use. A phantom study showed that the maximum depth of visibility (5.5mm for a 3.6mm blood vessel) is sufficient to visualize blood vessels in typical locations for peripheral venous and arterial access. A quantitative comparison of the VascuLuminator and to two other vessel imaging devices, using reflection of near-infrared light instead of transillumination, was conducted. The VascuLuminator is able to decrease failure at first attempt in blood withdrawal in pediatric patients from 10/80 (13%) to 1/45 (2%; P=.05).

Camera and instrument holders and their clinical value in minimally invasive surgery.

During minimally invasive procedures an assistant is controlling the laparoscope. Ideally, the surgeon should be able to manipulate all instruments including the camera him/herself, to avoid communication problems and disturbing camera movements. Camera holders return camera-control to the surgeon and stabilize the laparoscopic image. An additional holder can be used to stabilize an extra laparoscopic instrument for retracting. A literature survey has been carried out giving an overview of the existing "robotic" and passive camera and instrument holders and, if available, results of their clinical value. Benefits and limitations were identified. Most studies showed that camera holders, passive and active, provide the surgeon with a more stable image and enables them to control their own view direction. Only the passive holders were suitable for holding instruments. Comparisons between different systems are reviewed. Both active and passive camera and instrument holders are functional, and may be helpful to perform solo-surgery. The benefits of active holders are questionable in relation to the performance of the much simpler passive designs.

A realistic 3-D gated cardiac phantom for quality control of gated myocardial perfusion SPET: the Amsterdam gated (AGATE) cardiac phantom.

A realistic 3-D gated cardiac phantom with known left ventricular (LV) volumes and ejection fractions (EFs) was produced to evaluate quantitative measurements obtained from gated myocardial single-photon emission tomography (SPET). The 3-D gated cardiac phantom was designed and constructed to fit into the Data Spectrum anthropomorphic torso phantom. Flexible silicone membranes form the inner and outer walls of the simulated left ventricle. Simulated LV volumes can be varied within the range 45-200 ml. The LV volume curve has a smooth and realistic clinical shape that is produced by a specially shaped cam connected to a piston. A fixed 70-ml stroke volume is applied for EF measurements. An ECG signal is produced at maximum LV filling by a controller unit connected to the pump. This gated cardiac phantom will be referred to as the Amsterdam 3-D gated cardiac phantom, or, in short, the AGATE cardiac phantom. SPET data were acquired with a triple-head SPET system. Data were reconstructed using filtered back-projection following pre-filtering and further processed with the Quantitative Gated SPECT (QGS) software to determine LV volume and EF values. Ungated studies were performed to measure LV volumes ranging from 45 ml to 200 ml. The QGS-determined LV volumes were systematically underestimated. For different LV combinations, the stroke volumes measured were consistent at 60-61 ml for 8-frame studies and 63-65 ml for 16-frame studies. QGS-determined EF values were slightly overestimated between 1.25% EF units for 8-frame studies and 3.25% EF units for 16-frame studies. In conclusion, the AGATE cardiac phantom offers possibilities for quality control, testing and validation of the whole gated cardiac SPET sequence, and testing of different acquisition and processing parameters and software.