Design, Realization, and Assessment of a High-Fidelity Physical Simulator for the Investigation of Childbirth-Induced Pelvic Floor Damage

Vaginal delivery is one of the main causes of pelvic floor damage, which can lead to short- and long-term clinical consequences called pelvic floor dysfunctions. The number of women affected by this pathology is continuously rising, representing both a medical issue and an important financial burden. Prevention represents the best strategy of care, but it requires a deep understanding of the injury mechanisms, which is currently lacking. Simulation can help to identify the main factors affecting a clinical event, reducing the need for in vivo investigations. However, current simulators poorly mimic the pelvic structures and do not provide any feedback. These limitations led to the development of an innovative high-fidelity physical simulator to study the mechanisms behind pelvic floor damage caused by vaginal delivery. Anatomically correct gynecological structures were realized using soft materials able to resemble human tissue behavior. Ad hoc stretch sensors were realized with conductive fabric and integrated into the simulator to evaluate tissue elongation caused by the passage of the fetal head. Evaluation of the simulator was carried out both in laboratory conditions and by involving expert clinicians. Gynecologists determined that the simulator is a valid teaching and training tool that is able to provide feedback on instantaneous pelvic floor elongation, thus potentially preventing induced tissue damage

Toward the design of a tailored training course for birth assistance: an Ethiopian experience.

Simulation in healthcare has already demonstrated extraordinary potential in high-income countries. However, to date, few authors have explored the possibility of applying simulation-based training in African settings, highlighting the necessity of need-based training protocols capable of addressing economic, social, and cultural aspects. In this framework, this research investigates the main features a simulation training course on umbilical cord care and placenta management should have to be considered effective and sustainable in an African healthcare environment. Local facilitators were identified as the best resources for defining course contents and providing technical lectures to mitigate cultural, linguistic, and social issues. For the training program, the design of a new low-cost medium-fidelity simulator was explored and a preliminary evaluation was performed. Finally, the propensity of 25 students to attend a simulation training course was investigated using a questionnaire. The attitude of the enrolled students was positive, endorsing the future introduction of simulation training into the educational offers of Ethiopian colleges

Neonatal intubation: what are we doing?

: How and when the forces are applied during neonatal intubation are currently unknown. This study investigated the pattern of the applied forces by using sensorized laryngoscopes during the intubation process in a neonatal manikin. Nine users of direct laryngoscope and nine users of straight-blade video laryngoscope were included in a neonatal manikin study. During each procedure, relevant forces were measured using a force epiglottis sensor that was placed on the distal surface of the blade. The pattern of the applied forces could be divided into three sections. With the direct laryngoscope, the first section showed either a quick rise of the force or a discontinuous rise with several peaks; after reaching the maximum force, there was a sort of plateau followed by a quick drop of the applied forces. With the video laryngoscope, the first section showed a quick rise of the force; after reaching the maximum force, there was an irregular and heterogeneous plateau, followed by heterogeneous decreases of the applied forces. Moreover, less forces were recorded when using the video laryngoscope.    Conclusions: This neonatal manikin study identified three sections in the diagram of the forces applied during intubation, which likely mirrored the three main phases of intubation. Overall, the pattern of each section showed some differences in relation to the laryngoscope (direct or video) that was used during the procedure. These findings may provide useful insights for improving the understanding of the procedure. What is Known: • Neonatal intubation is a life-saving procedure that requires a skilled operator and may cause direct trauma to the tissues and precipitate adverse reactions. • Intubation with a videolaryngoscope requires less force than with a direct laryngoscope, but how and when the forces are applied during the whole neonatal intubation procedure are currently unknown. What is New: • Forces applied to the epiglottis during intubation can be divided into three sections: (i) an initial increase, (ii) a sort of plateau, and (iii) a decrease. • The pattern of each section shows some differences in relation to the laryngoscope (direct or videolaryngoscope) that is used during the procedure

Applied forces with direct versus indirect laryngoscopy in neonatal intubation: a randomized crossover mannequin study

Purpose: In adult mannequins, videolaryngoscopy improves glottic visualization with lower force applied to upper airway tissues and reduced task workload compared with direct laryngoscopy. This trial compared oropharyngeal applied forces and subjective workload during direct vs indirect (video) laryngoscopy in a neonatal mannequin. Methods: We conducted a randomized crossover trial of intubation with direct laryngoscopy, straight blade videolaryngoscopy, and hyperangulated videolaryngoscopy in a neonatal mannequin. Thirty neonatal/pediatric/anesthesiology consultants and residents participated. The primary outcome measure was the maximum peak force applied during intubation. Secondary outcome measures included the average peak force applied during intubation, time needed to intubate, and subjective workload. Results: Direct laryngoscopy median forces on the epiglottis were 8.2 N maximum peak and 6.8 N average peak. Straight blade videolaryngoscopy median forces were 4.7 N maximum peak and 3.6 N average peak. Hyperangulated videolaryngoscopy median forces were 2.8 N maximum peak and 2.1 N average peak. The differences were significant between direct laryngoscopy and straight blade videolaryngoscopy, and between direct laryngoscopy and hyperangulated videolaryngoscopy. Significant differences were also found in the top 10th percentile forces on the epiglottis and palate, but not in the median forces on the palate. Time to intubation and subjective workload were comparable with videolaryngoscopy vs direct laryngoscopy. Conclusions: The lower force applied during videolaryngoscopy in a neonatal mannequin model suggests a possible benefit in reducing potential patient harm during intubation, but the clinical implications require assessment in future studies. Registration: ClinicalTrials.gov (NCT05197868); registered 20 January 2022

High Fidelity Neonatal Pneumothorax Simulator

PNEUMOTHORAX (PTX) is the presence of air in the pleural space, which causes a partial or complete collapse of the lung. Such collapse can lead to major clinical complications including death. Commercial solutions and research prototypes are currently available. Commercial simulators provide a poor simulation of the PTX, reduced to an empty area beyond a dedicated access site, i.e. usually are placed in the wrong intercostal space. The research prototypes describe low-fidelity simulators and they present the same drawbacks of commercial simulators. Aim of this work, is the design, realization and preliminary assessment of a high-fidelity neonatal pneumothorax simulator that reproduces both the correct anatomy of the newborn' s chest and the PTX physiology. Chest tension is actively obtained through ad-hoc designed hardware and software components. The syringe plunger return feedback is reproduced by two pressurized airtight chambers. Finally, the simulator has two needle insertion areas in the third right and left ISs that provide the physiological tissue perforation feedback to the physician. Insertion areas were made with two self-sealing and replaceable pads for theoretically unlimited use of the device. Preliminary results confirmed the simulator as a valid technological solution for high-fidelity training course for neonatologists and paediatric residents. Future efforts will be dedicated to carry out specific protocol for system validation. A comparison of the obtained results with that one reachable with other commercial PTX simulators could be also interesting for validating the proposed model

Design and preliminary validation of a high-fidelity vascular simulator for robot-assisted manipulation

Abstract The number of robot-assisted minimally invasive surgeries is increasing annually, together with the need for dedicated and effective training. Surgeons need to learn how to address the novel control modalities of surgical instruments and the loss of haptic feedback, which is a common feature of most surgical robots. High-fidelity physical simulation has proved to be a valid training tool, and it might help in fulfilling these learning needs. In this regard, a high-fidelity sensorized simulator of vascular structures was designed, fabricated and preliminarily validated. The main objective of the simulator is to train novices in robotic surgery to correctly perform vascular resection procedures without applying excessive strain to tissues. The vessel simulator was integrated with soft strain sensors to quantify and objectively assess manipulation skills and to provide real-time feedback to the trainee during a training session. Additionally, a portable and user-friendly training task board was produced to replicate anatomical constraints. The simulator was characterized in terms of its mechanical properties, demonstrating its realism with respect to human tissues. Its face, content and construct validity, together with its usability, were assessed by implementing a training scenario with 13 clinicians, and the results were generally positive

Automatic Lung Segmentation in CT Images with Accurate Handling of the Hilar Region

A fully automated and three-dimensional (3D) segmentation method for the identification of the pulmonary parenchyma in thorax X-ray computed tomography (CT) datasets is proposed. It is meant to be used as pre-processing step in the computer-assisted detection (CAD) system for malignant lung nodule detection that is being developed by the Medical Applications in a Grid Infrastructure Connection (MAGIC-5) Project. In this new approach the segmentation of the external airways (trachea and bronchi), is obtained by 3D region growing with wavefront simulation and suitable stop conditions, thus allowing an accurate handling of the hilar region, notoriously difficult to be segmented. Particular attention was also devoted to checking and solving the problem of the apparent ‘fusion’ between the lungs, caused by partial-volume effects, while 3D morphology operations ensure the accurate inclusion of all the nodules (internal, pleural, and vascular) in the segmented volume. The new algorithm was initially developed and tested on a dataset of 130 CT scans from the Italung-CT trial, and was then applied to the ANODE09-competition images (55 scans) and to the LIDC database (84 scans), giving very satisfactory results. In particular, the lung contour was adequately located in 96% of the CT scans, with incorrect segmentation of the external airways in the remaining cases. Segmentation metrics were calculated that quantitatively express the consistency between automatic and manual segmentations: the mean overlap degree of the segmentation masks is 0.96 ± 0.02, and the mean and the maximum distance between the mask borders (averaged on the whole dataset) are 0.74 ± 0.05 and 4.5 ± 1.5, respectively, which confirms that the automatic segmentations quite correctly reproduce the borders traced by the radiologist. Moreover, no tissue containing internal and pleural nodules was removed in the segmentation process, so that this method proved to be fit for the use in the framework of a CAD system. Finally, in the comparison with a two-dimensional segmentation procedure, inter-slice smoothness was calculated, showing that the masks created by the 3D algorithm are significantly smoother than those calculated by the 2D-only procedure