Development and assessment of the performance of a shared ventilatory system that uses clinically available components to individualize tidal volumes.

OBJECTIVES: To develop and assess a system for shared ventilation using clinically available components to individualize tidal volumes. DESIGN: Evaluation and in vitro validation study SETTING: Ventilator shortage during the SARS-CoV-2 pandemic. PARTICIPANTS: The team consisted of physicians, bioengineers, computer programmers, and medical technology professionals. METHODS: Using clinically available components, a system of ventilation consisting of two ventilatory limbs was assembled and connected to a ventilator. Monitors for each limb were developed using open-source software. Firstly, the effect of altering ventilator settings on tidal volumes delivered to each limb was determined. Secondly, the impact of altering the compliance and resistance of one limb on the tidal volumes delivered to both limbs was analysed. Experiments were repeated three times to determine system variability. RESULTS: The system permitted accurate and reproducible titration of tidal volumes to each limb over a range of ventilator settings and simulated lung conditions. Alteration of ventilator inspiratory pressures, of respiratory rates, and I:E ratio resulted in very similar tidal volumes delivered to each limb. Alteration of compliance and resistance in one limb resulted in reproducible alterations in tidal volume to that test lung, with little change to tidal volumes in the other lung. All tidal volumes delivered were reproducible. CONCLUSIONS: We demonstrate the reliability of a shared ventilation system assembled using commonly available clinical components that allows titration of individual tidal volumes. This system may be useful as a strategy of last resort for Covid-19, or other mass casualty situations, where the need for ventilators exceeds supply.

The development and preliminary evaluation of a clinician e-learning training platform for a neonatal sepsis risk monitor for use in ICU settings.

BACKGROUND: Training clinicians on the use of hospital-based patient monitoring systems (PMS) is vital to mitigate the risk of use errors and of frustration using these devices, especially when used in ICU settings. PMS training is typically delivered through face-to-face training sessions in the hospital. However, it is not always feasible to deliver training in this format to all clinical staff given some constraints (e.g., availability of staff and trainers to attend in-person training sessions and the costs associated with face-to-face training). OBJECTIVE: The literature indicates that E-learning has the potential to mitigate barriers associated with time restrictions for trainers and trainees and evidence shows it to be more flexible, and convenient for learners in healthcare settings. This study aimed to develop and carry out a preliminary evaluation via a case study of an e-learning training platform designed for a novel neonatal sepsis risk monitor system (Digi-NewB). METHODS: A multi-modal qualitative research case study approach was used, including the analysis of three qualitative data sources: (i) audio/video recordings of simulation sessions in which participants were asked to operate the system as intended (e.g., update the clinical observations and monitor the sepsis risk), (ii) interviews with the simulation participants and an attending key opinion leader (KOL), who observed all simulation sessions, and (iii) post-simulation survey. RESULTS: After receiving ethical approval for the study, nine neonatal intensive care unit (NICU) nurses completed the online training and participated in the simulation and follow-up interview sessions. The KOL was also interviewed, and seven out of the nine NICU nurses answered the post-simulation survey. The video/audio analysis of the simulations revealed that participants were able to use and interpret the Digi-NewB interface. Interviews with simulation participants and the KOL, and feedback extracted from the survey, revealed that participants were overall satisfied with the training platform and perceived it as an efficient and effective method to deliver medical device training. CONCLUSIONS: This study developed an online training platform to train clinicians in the use of a critical care medical device and carried out a preliminary evaluation of the platform via a case study. The e-learning platform was designed to supplement and enhance other training approaches. Further research is required to evaluate the effectiveness of this approach.

Key requirements of a video-call system in a critical care department as discovered during the rapid development of a solution to address COVID-19 visitor restrictions.

The COVID-19 pandemic necessitated stringent visitor restrictions in critical care departments worldwide, creating challenges in keeping family members connected to patients and clinical staff. Previous studies have examined how hospitals addressed this challenge by repurposing existing tele-ICU systems or by using personal smartphones as a workaround and have analyzed clinical and family feedback. This case report addresses the experience of rapidly implementing a video-call system in the critical care department of a tertiary referral hospital that had no prior video-call system in place, detailing the key requirements in that setting. The 24 requirements were identified via interviews and surveys to both clinical and technical professionals. The top requirements identified were sound and video quality, usability for clinical staff, call control by staff, and patient privacy. From tailoring a video-call solution for this setting, we learned that video-endpoint selection is a key design decision. The initial proposal was to use wireless tablets, but the selection of a large wired video-endpoint allowed us to better address the requirements in the critical care setting. This was based on several characteristics of the large wired video-endpoint, including: high-fidelity video and sound, with directional noise-cancelling; large touch-screen setup for minimal-click navigation; wired as well as wireless connectivity.

Augmenting Critical Care Patient Monitoring Using Wearable Technology: Review of Usability and Human Factors.

BACKGROUND: Continuous monitoring of the vital signs of critical care patients is an essential component of critical care medicine. For this task, clinicians use a patient monitor (PM), which conveys patient vital sign data through a screen and an auditory alarm system. Some limitations with PMs have been identified in the literature, such as the need for visual contact with the PM screen, which could result in reduced focus on the patient in specific scenarios, and the amount of noise generated by the PM alarm system. With the advancement of material science and electronic technology, wearable devices have emerged as a potential solution for these problems. This review presents the findings of several studies that focused on the usability and human factors of wearable devices designed for use in critical care patient monitoring. OBJECTIVE: The aim of this study is to review the current state of the art in wearable devices intended for use by clinicians to monitor vital signs of critical care patients in hospital settings, with a focus on the usability and human factors of the devices. METHODS: A comprehensive literature search of relevant databases was conducted, and 20 studies were identified and critically reviewed by the authors. RESULTS: We identified 3 types of wearable devices: tactile, head-mounted, and smartwatch displays. In most cases, these devices were intended for use by anesthesiologists, but nurses and surgeons were also identified as potentially important users of wearable technology in critical care medicine. Although the studies investigating tactile displays revealed their potential to improve clinical monitoring, usability problems related to comfort need to be overcome before they can be considered suitable for use in clinical practice. Only a few studies investigated the usability and human factors of tactile displays by conducting user testing involving critical care professionals. The studies of head-mounted displays (HMDs) revealed that these devices could be useful in critical care medicine, particularly from an ergonomics point of view. By reducing the amount of time the user spends averting their gaze from the patient to a separate screen, HMDs enable clinicians to improve their patient focus and reduce the potential of repetitive strain injury. CONCLUSIONS: Researchers and designers of new wearable devices for use in critical care medicine should strive to achieve not only enhanced performance but also enhanced user experience for their users, especially in terms of comfort and ease of use. These aspects of wearable displays must be extensively tested with the intended end users in a setting that properly reflects the intended context of use before their adoption can be considered in clinical settings.

Novel Interface Designs for Patient Monitoring Applications in Critical Care Medicine: Human Factors Review.

BACKGROUND: The patient monitor (PM) is one of the most commonly used medical devices in hospitals worldwide. PMs are used to monitor patients' vital signs in a wide variety of patient care settings, especially in critical care settings, such as intensive care units. An interesting observation is that the design of PMs has not significantly changed over the past 2 decades, with the layout and structure of PMs more or less unchanged, with incremental changes in design being made rather than transformational changes. Thus, we believe it well-timed to review the design of novel PM interfaces, with particular reference to usability and human factors. OBJECTIVE: This paper aims to review innovations in PM design proposed by researchers and explore how clinicians responded to these design changes. METHODS: A literature search of relevant databases, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, identified 16 related studies. A detailed description of the interface design and an analysis of each novel PM were carried out, including a detailed analysis of the structure of the different user interfaces, to inform future PM design. The test methodologies used to evaluate the different designs are also presented. RESULTS: Most of the studies included in this review identified some level of improvement in the clinician's performance when using a novel display in comparison with the traditional PM. For instance, from the 16 reviewed studies, 12 studies identified an improvement in the detection and response times, and 10 studies identified an improvement in the accuracy or treatment efficiency. This indicates that novel displays have the potential to improve the clinical performance of nurses and doctors. However, the outcomes of some of these studies are weakened because of methodological deficiencies. These deficiencies are discussed in detail in this study. CONCLUSIONS: More careful study design is warranted to investigate the user experience and usability of future novel PMs for real time vital sign monitoring, to establish whether or not they could be used successfully in critical care. A series of recommendations on how future novel PM designs and evaluations can be enhanced are provided.

Functional safety of health information technology.

In an effort to improve patient safety and reduce adverse events, there has been a rapid growth in the utilisation of health information technology (HIT). However, little work has examined the safety of the HIT systems themselves, the methods used in their development or the potential errors they may introduce into existing systems. This article introduces the conventional safety-related systems development standard IEC 61508 to the medical domain. It is proposed that the techniques used in conventional safety-related systems development should be utilised by regulation bodies, healthcare organisations and HIT developers to provide an assurance of safety for HIT systems. In adopting the IEC 61508 methodology for HIT development and integration, inherent problems in the new systems can be identified and corrected during their development. Also, IEC 61508 should be used to develop a healthcare-specific standard to allow stakeholders to provide an assurance of a system's safety.