Use of a Novel Three-Dimensional Model to Teach Ultrasound-guided Subclavian Vein Cannulation.

Background: Central venous cannulation is an essential skill in perioperative and critical care medicine. Ultrasound guidance is the standard of care for femoral and internal jugular vein access, with the subclavian vein being perceived to be less amenable to ultrasound-guided (UG) insertion, resulting in a lack of procedural competency and low cannulation rate. There is a paucity of resources and a lack of experience among staff physicians to effectively instruct trainees. Simulation-based medical education has the potential to help maintain high-stakes, infrequently performed skills and counteract possible unrecognized skill decline. We aimed to create a novel, low-cost, high-fidelity three-dimensional (3D) model for UG subclavian vein (UG-SCV) access with an accompanying curriculum to improve this important skill. Methods: A curriculum was created consisting of preparatory material reviewing UG-SCV access, followed by an in-person didactic lecture focusing on ultrasound use and management of complications and a deliberate practice session scanning volunteers and practicing UG vascular puncture on a 3D model. A qualitative usability test design was used to assess the validity of the curriculum in trainees with advanced vascular access skills (anesthesiologists). Participants were second-year anesthesia residents, anesthesia fellows, and staff physicians. Focus groups conducted after each session explored the face validity of the model and curriculum. By applying a usability design, the curriculum was optimized and finalized. Results: Between September 2020 and February 2021, 28 participants tested the curriculum. The focus groups ensured that the curriculum achieved its objective, with iterative changes made after each session in a quality improvement framework Plan-Do-Study-Act approach. After the third cycle, minimal changes were suggested, and the curriculum and 3D model were finalized. An additional group of participants was used to ensure that no new input would help improve the curriculum further. Conclusions: A focused curriculum for enhancing skills in UG-SCV cannulation using a novel 3D model was successfully implemented and validated through a usability test design. This curriculum is better targeted for practitioners experienced in central venous access to master a subclavian approach and maintain their skill level.

Intraoperative air embolism diagnosis and treatment using hyperbaric oxygen therapy after craniotomy: illustrative case.

BACKGROUND: This report describes the use of hyperbaric oxygen therapy for the acute management of an intraoperative air embolism encountered during a neurosurgical procedure. Furthermore, the authors highlight the concomitant diagnosis of tension pneumocephalus requiring evacuation prior to hyperbaric therapy. OBSERVATIONS: A 68-year-old male developed acute ST-segment elevation and hypotension during elective disconnection of a posterior fossa dural arteriovenous fistula. The semi-sitting position had been used to minimize cerebellar retraction, raising the concern for acute air embolism. Intraoperative transesophageal echocardiography was utilized to establish the diagnosis of air embolism. The patient was stabilized on vasopressor therapy, and immediate postoperative computed tomography revealed air bubbles in the left atrium along with tension pneumocephalus. He underwent urgent evacuation for the tension pneumocephalus followed by hyperbaric oxygen therapy to manage the hemodynamically significant air embolism. The patient was eventually extubated and went on to fully recover; a delayed angiogram revealed complete cure of the dural arteriovenous fistula. LESSONS: Hyperbaric oxygen therapy should be considered for an intracardiac air embolism resulting in hemodynamic instability. In the postoperative neurosurgical setting, care should be taken to exclude pneumocephalus requiring operative intervention prior to hyperbaric therapy. A multidisciplinary management approach facilitated expeditious diagnosis and management for the patient.

Precontouring Plates for MIS Bilateral Femur Osteosynthesis Using a Patient-Specific 3D Printed Model: A Case Report.

CASE: A 27-year-old woman with increasing bilateral thigh pain and underlying diagnosis of dysosteosclerosis was diagnosed with bilateral impending pathological femur fractures. Both femurs exhibited abnormal morphology with bowing, thickened cortices, and narrow intramedullary canals. We planned minimally invasive prophylactic plate osteosynthesis. Computed tomography scans of both femora were obtained and used to generate 3-dimensional (3D) printed models. Osteosynthesis plates were precontoured to fit the 3D models and sterilized, and prophylactic fixation was performed using a minimally invasive submuscular technique. CONCLUSION: 3D printed models aided in precontouring fixation plates in a case with challenging bony anatomy, enabling minimally invasive surgery.

Open ventilator evaluation framework: A synthesized database of regulatory requirements and technical standards for emergency use ventilators from Australia, Canada, UK, and US.

Development of emergency use ventilators has attracted significant attention and resources during the COVID-19 pandemic. To facilitate mass collaboration and accelerate progress, many groups have adopted open-source development models, inspired by the long history of open-source development in software. According to the Open-source Hardware Association (OSHWA), Open-source Hardware (OSH) is a term for tangible artifacts - machines, devices, or other physical things - whose design has been released to the public in such a way that anyone can make, modify, and use them. One major obstacle to translating the growing body of work on open-source ventilators into clinical practice is compliance with regulations and conformance with mandated technical standards for effective performance and device safety. This is exacerbated by the inherent complexity of the regulatory process, which is tailored to traditional centralized development models, as well as the rapid changes and alternative pathways that have emerged during the pandemic. As a step in addressing this challenge, this paper provides developers, evaluators, and potential users of emergency ventilators with the first iteration of a pragmatic, open-source assessment framework that incorporates existing regulatory guidelines from Australia, Canada, UK and USA. We also provide an example evaluation for one open-source emergency ventilator design. The evaluation process has been divided into three levels: 1. Adequacy of open-source project documentation; 2. Clinical performance requirements, and 3. Conformance with technical standards.

Development, manufacturing, and preliminary validation of a reusable half-face respirator during the COVID-19 pandemic.

INTRODUCTION: The COVID-19 pandemic has led to widespread shortages of N95 respirators and other personal protective equipment (PPE). An effective, reusable, locally-manufactured respirator can mitigate this problem. We describe the development, manufacture, and preliminary testing of an open-hardware-licensed device, the "simple silicone mask" (SSM). METHODS: A multidisciplinary team developed a reusable silicone half facepiece respirator over 9 prototype iterations. The manufacturing process consisted of 3D printing and silicone casting. Prototypes were assessed for comfort and breathability. Filtration was assessed by user seal checks and quantitative fit-testing according to CSA Z94.4-18. RESULTS: The respirator originally included a cartridge for holding filter material; this was modified to connect to standard heat-moisture exchange (HME) filters (N95 or greater) after the cartridge showed poor filtration performance due to flow acceleration around the filter edges, which was exacerbated by high filter resistance. All 8 HME-based iterations provided an adequate seal by user seal checks and achieved a pass rate of 87.5% (N = 8) on quantitative testing, with all failures occurring in the first iteration. The overall median fit-factor was 1662 (100 = pass). Estimated unit cost for a production run of 1000 using distributed manufacturing techniques is CAD $15 in materials and 20 minutes of labor. CONCLUSION: Small-scale manufacturing of an effective, reusable N95 respirator during a pandemic is feasible and cost-effective. Required quantities of reusables are more predictable and less vulnerable to supply chain disruption than disposables. With further evaluation, such devices may be an alternative to disposable respirators during public health emergencies. The respirator described above is an investigational device and requires further evaluation and regulatory requirements before clinical deployment. The authors and affiliates do not endorse the use of this device at present.

Echocardiographic assessment of left ventricular function in ex situ heart perfusion using pump-supported and passive afterload working mode: a pilot study.

Ex situ heart perfusion (ESHP) has been developed to decrease cold ischemia time and allow metabolic assessment of donor hearts prior to transplantation. Current clinical ESHP systems preserve the heart in an unloaded condition and only evaluate the cardiac metabolic profile. In this pilot study we performed echocardiographic functional assessment using two alternative systems for left ventricular (LV) loading: pump supported afterload working mode (SAM) and passive afterload working modes (PAM). Six hearts were procured from male Yorkshire pigs. During cold ischemia, hearts were mounted on our custom made ESHP circuit and a 3D-printed enclosure for the performance of echocardiography with a standard TEE probe. Following perfusion with Langherdorf mode of the unloaded heart, the system was switched into different working modes to allow LV loading and functional assessment: pump supported (SAM) and passive (PAM). Echocardiographic assessment of left ventricular function in the donor hearts was performed in vivo and at 1 h of ESHP with SAM, after 4.5 h with PAM and after 5.5 h with SAM. We obtained good quality epicardial echocardiographic images at all time points allowing a comprehensive LV systolic assessment. All indices showed a decrease in LV systolic function throughout the trial with the biggest drop after heart harvesting. We demonstrated the feasibility of echocardiographic functional assessment during ESHP and two different working modes. The expected LV systolic dysfunction consisted of a reduction in EF, FAC, FS, and strain throughout the experiment with the most significant decrease after harvesting.

Evaluation of a Patient-Specific, Low-Cost, 3-Dimensional-Printed Transesophageal Echocardiography Human Heart Phantom.

OBJECTIVE: Currently available 3-dimensional (3D) modeling and printing techniques allow for the creation of patient-specific models based on 3D medical imaging data. The authors hypothesized that a low-cost, patient-specific, cardiac computed tomography-based phantom, created using desktop 3D printing and casting, would have comparable image quality, accuracy, and usability to an existing commercially available echocardiographic phantom. DESIGN: Blinded comparative study. SETTING: Simulation laboratory at a single academic institution. PARTICIPANTS: Voluntary cardiac anesthesiologists at a single academic institution. INTERVENTIONS: Stage 1 of the study consisted of an online questionnaire in which a set of basic transesophageal echocardiography (TEE) views obtained from the 3D printed phantom and commercial phantom were presented to participants, who had to identify the views and evaluate their fidelity to clinical images on a Likert scale. In stage 2, participants performed an unblinded basic TEE examination on both phantoms. MEASUREMENTS AND MAIN RESULTS: The time needed to acquire each basic view was recorded. Overall usability of the phantoms was assessed through a questionnaire. The participants could recognize most of the views. Fidelity ratings for both phantoms were similar (p < 0.05), with the exception of a midesophageal 2-chamber view that was observed better on the 3D printed phantom. The time required to obtain the views was shorter for the 3D printed phantom, although not statistically significant for most views. The overall user experience was better for the 3D phantom for all categories examined (p < 0.05). CONCLUSIONS: The study suggested that a 3D-printed TEE phantom is comparable with the commercially available one with good usability.

Subject validation of reusable N95 stop-gap filtering facepiece respirators in COVID-19 pandemic.

INTRODUCTION: The COVID-19 pandemic has unveiled widespread shortages of personal protective equipment including N95 respirators. Several centers are developing reusable stop-gap respirators as alternatives to disposable N95 respirators during public health emergencies, using techniques such as 3D-printing, silicone moulding and plastic extrusion. Effective sealing of the mask, combined with respiratory filters should achieve 95% or greater filtration of particles less than 1um. Quantitative fit-testing (QNFT) data from these stop-gap devices has not been published to date. Our team developed one such device, the "SSM", and evaluated it using QNFT. METHODS: Device prototypes were iteratively evaluated for comfort, breathability and communication, by team members wearing them for 15-30min. The fit and seal were assessed by positive and negative pressure user seal checks. The final design was then formally tested by QNFT, according to CSA standard Z94.4-18 in 40 volunteer healthcare providers. An overall fit-factor >100 is the passing threshold. Volunteers were also tested by QNFT on disposable N95 masks which had passed qualitative fit testing (QLFT) by institutional Occupational Health and Safety Department. RESULTS: The SSM scored 3.5/5 and 4/5 for comfort and breathability. The median overall harmonic mean fit-factors of disposable N95 and SSM were 137.9 and 6316.7 respectively. SSM scored significantly higher than disposable respirators in fit-test runs and overall fit-factors (p <0.0001). Overall passing rates in disposable and SSM respirators on QNFT were 65% and 100%. During dynamic runs, passing rates in disposable and SSM respirators were 68.1% and 99.4%; harmonic means were 73.7 and 1643. CONCLUSIONS: We present the design and validation of a reusable N95 stop-gap filtering facepiece respirator that can match existent commercial respirators. This sets a precedence for adoption of novel stop-gap N95 respirators in emergency situations.

Personalized Ventilation to Multiple Patients Using a Single Ventilator: Description and Proof of Concept.

OBJECTIVES: To design and test a ventilator circuit that can be used for ventilation of two or more patients with a single ventilator, while allowing individualization of tidal volume, fractional concentration of oxygen, and positive end-expiratory pressure to each patient, irrespective of the other patient's respiratory system mechanics. DESIGN: Description and proof of concept studies. SETTINGS: Respiratory therapy laboratory. SUBJECTS: Ventilation of mechanical test lungs. INTERVENTIONS: Following a previously advocated design, we used components readily available in our hospital to assemble two "bag-in-a-box" breathing circuits. Each patient circuit consisted of a flexible bag in a rigid container connected via one-way valve to a test lung, along with an inline positive end-expiratory pressure valve, connected to the ventilator's expiratory limb. Compressed gas fills the bags during "patient" exhalation. During inspiration, gas from the ventilator, in pressure control mode, enters the containers and displaces gas from the bags to the test lungs. We varied tidal volume, "respiratory system" compliance, and positive end-expiratory pressure in one lung and observed the effect on the tidal volume of the other. MEASUREMENTS AND MAIN RESULTS: We were able to obtain different tidal volume, dynamic driving pressure, and positive end-expiratory pressure in the two lungs under widely different compliances in both lungs. Complete obstruction, or disconnection at the circuit connection to one test lung, had minimal effect (< 5% on average) on the ventilation to the co-ventilated lung. CONCLUSIONS: A secondary circuit "bag-in-the-box" system enables individualized ventilation of two lungs overcoming many of the concerns of ventilating more than one patient with a single ventilator.

Low-cost three-dimensional printed phantom for neuraxial anesthesia training: Development and comparison to a commercial model.

METHODS: Anonymized CT DICOM data was segmented to create a 3D model of the lumbar spine. The 3D model was modified, placed inside a digitally designed housing unit and fabricated on a desktop 3D printer using polylactic acid (PLA) filament. The model was filled with an echogenic solution of gelatin with psyllium fiber. Twenty-two staff anesthesiologists performed a spinal and epidural on the 3D printed simulator and a commercially available Simulab phantom. Participants evaluated the tactile and ultrasound imaging fidelity of both phantoms via Likert-scale questionnaire. RESULTS: The 3D printed neuraxial phantom cost $13 to print and required 25 hours of non-supervised printing and 2 hours of assembly time. The 3D printed phantom was found to be less realistic to surface palpation than the Simulab phantom due to fragility of the silicone but had significantly better fidelity for loss of resistance, dural puncture and ultrasound imaging than the Simulab phantom. CONCLUSION: Low-cost neuraxial phantoms with fidelity comparable to commercial models can be produced using CT data and low-cost infrastructure consisting of FLOS software and desktop 3D printers.

Description of a Novel Set-up for Functional Echocardiographic Assessment of Left Ventricular Performance During Ex Vivo Heart Perfusion.

Ex vivo heart perfusion (EVHP) is a new technology aimed at decreasing cold ischemia time and evaluating cardiac function before transplanting a donor heart. In an experimental EVHP swine model, we tested a 3D-printed custom-made set-up to perform surface echocardiography on an isolated beating heart during left ventricular loading. The views obtained at any time point were equivalent to standard transesophageal and transthoracic views. A decrease in left ventricular function during EVHP was observed in all experiments.

Summative Objective Structured Clinical Examination Assessment at the End of Anesthesia Residency for Perioperative Ultrasound.

While standardized examinations and data from simulators and phantom models can assess knowledge and manual skills for ultrasound, an Objective Structured Clinical Examination (OSCE) could assess workflow understanding. We recruited 8 experts to develop an OSCE to assess workflow understanding in perioperative ultrasound. The experts used a binary grading system to score 19 graduating anesthesia residents at 6 stations. Overall average performance was 86.2%, and 3 stations had an acceptable internal reliability (Kuder-Richardson formula 20 coefficient >0.5). After refinement, this OSCE can be combined with standardized examinations and data from simulators and phantom models to assess proficiency in ultrasound.

Use of 3-Dimensional Printing to Create Patient-Specific Thoracic Spine Models as Task Trainers.

BACKGROUND AND OBJECTIVES: Thoracic epidural anesthesia is a technically challenging procedure with a high failure rate of 24% to 32% nationwide. Residents in anesthesiology have limited opportunities to practice this technique adequately, and there are no training tools available for this purpose. Our objective was to build a low-cost patient-specific thoracic epidural training model. METHODS: We obtained thoracic computed tomography scan data from patients with normal and kyphotic spine. The thoracic spine was segmented from the scan, and a 3-dimensional model of the spine was generated and printed. It was then placed in a customized wooden box and filled with different types of silicone to mimic human tissues. Attending physicians in our institution then tested the final model. They were asked to fill out a brief questionnaire after the identification of the landmarks and epidural space using ultrasound and real-time performance for a thoracic epidural on the model (Supplemental Digital Content 1, http://links.lww.com/AAP/A197). Likert scoring system was used for scoring. RESULTS: The time to develop this simulator model took less than 4 days, and the materials cost approximately $400. Fourteen physicians tested the model for determining the realistic sensation while palpating the spinous process, needle entry through the silicone, the "pop" sensation and ultrasound fidelity of the model. Whereas the tactile fidelity scores were "neutral" (3.08, 3.06, and 3.0, respectively), the ultrasound guidance and overall suitability for residents were highly rated as being the most realistic (4.85 and 4.0, respectively). CONCLUSIONS: It is possible to develop homemade, low-cost, patient-specific, and high-fidelity ultrasound guidance simulators for resident training in thoracic epidurals using 3-dimensional printing technology.

Regional Heterogeneity in the Mitral Valve Apparatus in Patients With Ischemic Mitral Regurgitation.

BACKGROUND: Apical displacement of the coaptation point of the mitral valve (MV) in response to ischemic mitral regurgitation (IMR) represents remodeling of the MV apparatus. Whereas it implies chronicity, it lacks specificity in discriminating normal from a significantly remodeled MV apparatus. Regional aspects of MV remodeling have shown superior value over global remodeling in predicting recurrence after MV repair for IMR. Quite possibly, presence of specific regional changes in MV geometry that are unique to chronic IMR patients could also be used to diagnose the presence and track progression of remodeling. Knowledge of these changes in MV apparatus in patients with IMR can possibly be used to identify patients for surgical intervention before irreversible remodeling occurs. METHODS: Three-dimensional transesophageal echocardiographic data were collected from patients who underwent MV surgery for IMR (IMR group, n = 66), and from patients with normal valvular and biventricular function (control group, n = 10). The acquired data of the MV were geometrically analyzed to make regional comparisons between the IMR and the control group to identify measurements that reliably differentiate normal from remodeled MVs. RESULTS: Lengthening of the middle potion of the anterior annulus (A2 regional perimeter: 11.149 mm versus 9.798 mm, p = 0.0041), larger nonplanarity angle (147.985 versus 140.720 degrees, p = 0.0459), and increased tenting angle of the posteromedial scallop of the posterior leaflet (P3 tenting angle: 44.354 versus 40.461 degrees, p = 0.0435) were sufficient in differentiating between IMR and the control group. CONCLUSIONS: Specific three-dimensional changes in MV geometry can be used to reliably identify a significantly remodeled valve apparatus.

Assessment of Perioperative Ultrasound Workflow Understanding: A Consensus.

OBJECTIVES: Understanding of the workflow of perioperative ultrasound (US) examination is an integral component of proficiency. Workflow consists of the practical steps prior to executing an US examination (eg, equipment operation). Whereas other proficiency components (ie, cognitive knowledge and manual dexterity) can be tested, workflow understanding is difficult to define and assess due to its contextual and institution-specific nature. The objective was to define the workflow components of specific perioperative US applications using an iterative process to reach a consensus opinion. DESIGN: Expert consensus, survey study. SETTING: Tertiary university hospital. PARTICIPANTS: This study sought expert consensus among a focus group of 9 members of an anesthesia department with experience in perioperative US. Afterward, 257 anesthesia faculty members from 133 academic centers across the United States were surveyed. INTERVENTIONS: A preliminary list of tasks was designed to establish the expectations of workflow understanding by an anesthesiology resident prior to clinical exposure to perioperative US. This list was modified by a focus group through an iterative process. Afterwards, a survey was sent to faculty members nationwide, and Likert scale ratings for each task were obtained and reviewed during a second round. MEASUREMENTS AND MAIN RESULTS: Consensus among members of the focus group was reached after 2 iterations. 72 participants responded to the nationwide survey (28%), and consensus was reached after the second round (Cronbach's α = 0.99, ICC = 0.99) on a final list of 46 workflow-related tasks. CONCLUSIONS: Specific components of perioperative US workflow were identified. Evaluation of workflow understanding may be combined with cognitive knowledge and manual dexterity testing for assessing proficiency in perioperative US.

Making three-dimensional echocardiography more tangible: a workflow for three-dimensional printing with echocardiographic data.

Three-dimensional (3D) printing is a rapidly evolving technology with several potential applications in the diagnosis and management of cardiac disease. Recently, 3D printing (i.e. rapid prototyping) derived from 3D transesophageal echocardiography (TEE) has become possible. Due to the multiple steps involved and the specific equipment required for each step, it might be difficult to start implementing echocardiography-derived 3D printing in a clinical setting. In this review, we provide an overview of this process, including its logistics and organization of tools and materials, 3D TEE image acquisition strategies, data export, format conversion, segmentation, and printing. Generation of patient-specific models of cardiac anatomy from echocardiographic data is a feasible, practical application of 3D printing technology.