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Objective: Our team set out to design and develop a low-cost 3D-printed liver transplant simulator. Design: The simulator comprises a 3D-printed recipient body cavity and the filled-fabric liver. Results: Validators perceived the model as valuable to education, noted that they would use the model at their institution and desired to integrate the model into their curriculum. In addition, the simulator was rated highly for ease of use (3.6/4), physical attributes (3.2/4) and user experience (4.4/5). Conclusion: The low-cost 3D-printed simulator for liver transplantation was highly rated in a multi-institutional validation and supports the use of simulation models in transplant surgery.

Pediatric obstructive sleep apnea impacts child and familial well-being. Airway management in patients with hypotonic pharyngeal conditions is complex. Some patients may benefit from continuous positive airway pressure or bilevel positive airway pressure, others may require further invasive measures for treatment. There is critical need for treatment alternatives for patients with pharyngeal hypotonia.This is a retrospective case series. Collaboratively with patients, families, biomedical engineers, and medical professionals, a long-term nasopharyngeal airway (NPA) was created to bypass upper airway obstruction. Two patients used a safety pin and tape attachment, and two patients used a novel 3D-printed, self-supporting nasal securement. All 4 patients had polysomnography before and during NPA use. Paired 1-tailedCompared to baseline polysomnography, repeat polysomnography with the NPA in place demonstrated statistically significant improvement for apnea-hypopnea index (75.8 ± 36.6 events/h to 8.9 ± 2.9 events/h,Current management of severe upper airway obstruction and obstructive sleep apnea in hypotonic pharyngeal conditions requires a team-based approach to care. A long-term NPA device may be an alternative or temporizing option to continuous positive airway pressure, upper airway surgery, or tracheostomy in children with pharyngeal hypotonia and severe obstructive sleep apnea. Larger studies of this approach are underway to assess efficacy in a range of obstructive sleep apnea severity in this population.Powell AR, Srinivasan S, Helman JL, et al. Novel treatment for hypotonic airway obstruction and severe obstructive sleep apnea using a nasopharyngeal airway device with 3D printing innovation.

Aim: Orofacial clefts are prevalent with limited access to surgical correction. To address this issue our objective was to create a low-cost, high-fidelity, 3D-printed Veau class II cleft palate surgical simulator. Materials & methods: A 3D-printed Veau class II cleft palate simulator was designed using de-identified computed tomography data and computer aided design software. The simulator then underwent multi-institutional expert otolaryngologist validation. Results: The Veau class II cleft palate simulator was rated on a scale of 1–5; 3.8 as a training tool, 4.20 as a competency evaluation tool and 4.20 as a rehearsal tool. The simulator was also rated as very relevant (4.20) and very useful (4.60). Conclusion: The low-cost, high-fidelity Veau II cleft palate simulator was rated highly for physical attributes, realism, performance and usefulness.

Endoscopic laryngeal cleft repair (ELCR) with endolaryngeal suturing is an advanced surgical skill. This study objective was to assess the validity of 3-dimensionally (3D) printed laryngeal suturing simulator for ELCR.Development and validation of a simulator for ELCR.An ELCR model was developed using 3D printed and readily available materials. Participants were surveyed before and after a simulation session using five-point Likert scale questions. Performance data was assessed using blinded expert video review and rated using a novel objective structured assessment of technical skills (OSATS) for endoscopic laryngeal suturing.Twenty-one participants ranging from residents to attendings completed the simulation session. Survey respondents reported on a five-point Likert scale that the model was "easy to use" and "quite realistic" (both mean of 4). Confidence improved significantly in 86% of participants (p 0.01). Overall OSATS scores (out of a total of 55) showed a median improvement in technical skills of 11.7 points (p = 0.004). OSATS demonstrated good intra-rater (κ = 0.689 and 0.677) and moderate inter-rater (κ = 0.573) reliability. Completion times improved from the first to the last suture by a median time of 512 to 350 s (decrease of 202 s, p = 0.002). Participants with no prior ELCR experience improved more than those with in vivo experience.This study demonstrates the validity of a simulator utilizing 3D printed larynges for ELCR. A novel OSATS for endoscopic laryngeal suturing was successfully implemented. Confidence, technical skills, and completion times improved with the use of the model across a variety of participants. Laryngoscope, 2022.

Importance: Prominotia has functional and esthetic impact for the child and family and proficiency in otoplasty requires experiential rehearsal. Objectives: To design and validate an anatomically accurate, 3D printed prominotia simulator for rehearsal of otoplasties. Methods: A 3D prominotia model was designed from a computed tomographic (CT) scan and edited in 3-matic software. Negative molds were 3D printed and filled with silicone. Expert surgeons performed an otoplasty procedure on these simulators and provided Likert-based feedback. Results: Six expert surgeons with a mean of 14.3 years of practice evaluated physical qualities, realism, performance, and value of the simulator. The simulator was rated on a scale of 1 (no value) to 5 (great value) and scored 3.83 as a training tool, 3.83 as a competency evaluation tool, and 4 as a rehearsal tool. Conclusions: Expert validation rated the otoplasty simulator highly in physical qualities, realism, performance, and value. With minor modifications, this model demonstrates valuable educational potential.

Objective: The COVID-19 pandemic has introduced a period of social isolation that has challenged the ability of providers to uphold in-person patient care. Although commonplace in pediatric otolaryngology, multidisciplinary clinics pose a unique challenge during this time due to increased infection risk from multiple patient-provider interactions. Guidance on the application of telemedicine for multidisciplinary clinics in pediatric otolaryngology is limited. Methods: We provide comprehensive guidance on best practices for conducting telemedicine visits for a number of multidisciplinary otolaryngology clinics using our experiences at a single tertiary care children’s hospital. A review of literature to support the adoption of telemedicine in multidisciplinary pediatric otolaryngology is also incorporated. Results: Telemedicine was successfully adopted for 7 multidisciplinary pediatric clinics with a variety of specialists: aerodigestive disorders, congenital hearing loss, microtia/aural atresia, orofacial clefting, sleep disorders, tracheostomy care, and velopharyngeal dysfunction. Conclusions: Telemedicine is feasible for a variety of multidisciplinary clinics and its optimization is critical for providing care to complex pediatric otolaryngology patients during the COVID-19 pandemic and beyond.

OBJECTIVES/HYPOTHESIS To analyze the use of highly translatable three-dimensional (3D)-printed auricular scaffolds with and without novel cartilage tissue inserts in a rodent model. STUDY DESIGN Preclinical rodent animal model. METHODS This prospective study assessed a single-stage 3D-printed auricular bioscaffold with or without porcine cartilage tissue inserts in an athymic rodent model. Digital Imaging and Communications in Medicine computed tomography images of a human auricle were segmented to create an external anatomic envelope filled with orthogonally interconnected spherical pores. Scaffolds with and without tissue inset sites were 3D printed by laser sintering bioresorbable polycaprolactone, then implanted subcutaneously in five rats for each group. RESULTS Ten athymic rats were studied to a goal of 24 weeks postoperatively. Precise anatomic similarity and scaffold integrity were maintained in both scaffold conditions throughout experimentation with grossly visible tissue ingrowth and angiogenesis upon explantation. Cartilage-seeded scaffolds had relatively lower rates of nonsurgical site complications compared to unseeded scaffolds with relatively increased surgical site ulceration, though neither met statistical significance. Histology revealed robust soft tissue infiltration and vascularization in both seeded and unseeded scaffolds, and demonstrated impressive maintenance of viable cartilage in cartilage-seeded scaffolds. Radiology confirmed soft tissue infiltration in all scaffolds, and biomechanical modeling suggested amelioration of stress in scaffolds implanted with cartilage. CONCLUSIONS A hybrid approach incorporating cartilage insets into 3D-printed bioscaffolds suggests enhanced clinical and histological outcomes. These data demonstrate the potential to integrate point-of-care tissue engineering techniques into 3D printing to generate alternatives to current reconstructive surgery techniques and avoid the demands of traditional tissue engineering. LEVEL OF EVIDENCE NA Laryngoscope, 131:1008-1015, 2021.

Caregivers frequently report poor quality of life (QOL) in children with sleep-disordered breathing (SDB). Our objective is to assess the correlation between caregiver- and child-reported QOL in children with mild SDB and identify factors associated with differences between caregiver and child report.Analysis of baseline data from a multi-institutional randomized trial.Pediatric Adenotonsillectomy Trial for Snoring, where children with mild SDB (obstructive apnea-hypopnea index3) were randomized to observation or adenotonsillectomy.The Pediatric Quality of Life Inventory (PedsQL) assessed baseline global QOL in participating children 5 to 12 years old and their caregivers. Caregiver and child scores were compared. Multivariable regression assessed whether clinical factors were associated with differences between caregiver and child report.PedsQL scores were available for 309 families (mean child age, 7.0 years). The mean caregiver-reported PedsQL score was higher at 75.2 (indicating better QOL) than the mean child-reported score of 67.9 (Caregiver- and child-reported global QOL in children with SDB was weakly correlated, more so for young children. In pediatric SDB, child-perceived QOL may be poorer than that reported by caregivers. Further research is needed to assess whether similar trends exist for disease-specific QOL metrics.

To examine whether a service guideline reducing postoperative opioid prescription quantities and caregiver-reported education to use nonopioid analgesics first are associated with caregiver-reported pain control after pediatric tonsillectomy.Prospective cohort study (July 2018-April 2019).Pediatric otolaryngology service at a tertiary academic children's hospital.Caregivers of patients aged 1 to 11 years undergoing tonsillectomy (N = 764) were surveyed 7 to 21 days after surgery regarding pain control, education to use nonopioid analgesics first, and opioid use. Respondents who were not prescribed opioids or had missing data were excluded. Logistic regression modeled caregiver-reported pain control as a function of service guideline implementation (December 2018) recommending 20 rather than 30 doses for postoperative opioid prescriptions and caregiver-reported analgesic education, adjusting for patient demographics.Among 430 respondents (56% response), 387 patients were included. The sample was 43% female with a mean age of 5.0 years (SD, 2.5). Pain control was reported as good (226 respondents, 58%) or adequate/poor (161 respondents, 42%). Mean opioid prescription quantity was 27 doses (SD, 7.9) before and 21 doses (SD, 6.1) after guideline implementation (Caregiver education to use nonopioid analgesics first may be a modifiable health care practice to improve pain control as postoperative opioid prescription quantities are reduced.

Treatment of upper airway obstruction (UAO) in hypotonic patients is challenging due to diffuse multilevel obstruction with lack of muscular airway tone. Currently available treatment options, ranging from palliative care to tracheostomy, either do not effectively treat UAO, or introduce significant morbidity. This study developed a non-surgical self-supported nasopharyngeal airway (ssNPA) device comprising a patency tube to bypass the obstruction and a flexible securement attachment to hold the device in a proper anatomic position without the use of adhesive or strap-based delivery systems. The ssNPA device has been used in two children: an 8 year and 8 months old male and a 17 year and 4 months old female both with quadriplegic cerebral palsy and severe obstructive sleep apnea (OSA). Results show that ssNPA has demonstrated the good tolerability and feasibility of effectively treating OSA in both patients, and Apnea/Hypopnea Index (AHI) was reduced by 92% and 88% for the 8 year and 8 months and 17 year and 4 months old patient, respectively.

Objectives: Telemedicine was increasingly adopted in otolaryngology as a result of the COVID-19 pandemic, but how it compares to in-person visits over the longitudinal course of the pandemic has not been characterized. This study compares telemedicine visits to in-person visits on measures of clinical efficiency and patient satisfaction. Methods: We examined all in-person and telemedicine encounters that occurred during the 13-month period from April 1, 2020 to April 30, 2021 at a pediatric otolaryngology clinic associated with a large tertiary care children’s hospital. We compared patient demographics, primary encounter diagnoses, completions, cancellations, no-shows, cycle time, and patient satisfaction. Results: A total of 19 541 (90.5%) in-person visits and 2051 (9.5%) telemedicine visits were scheduled over the study period. There was no difference in patient age or gender between the visit types. There was a difference in race (75% White or Caucasian for in-person and 73% for telemedicine, P = .007) and average travel distance (53.3 miles for in-person vs 71.0 for telemedicine, P = .000). The most common primary diagnosis was Eustachian tube dysfunction for in-person visits (11.8%) and sleep disordered breathing for telemedicine visits (13.7%). Completion rate was greater for telemedicine visits (52.4% in-person vs 62.5% telemedicine). Cancellations were greater for in-person visits (42.6% in-person vs 24.2% telemedicine), but no-shows were greater for telemedicine (5.0% in-person vs 13.3% telemedicine, all P = .000). Average cycle time was shorter for telemedicine visits (56.5 minutes in-person vs 47.6 minutes telemedicine, P = .000). Patient satisfaction with provider interactions and overall care experience was high for both visit types. Conclusions: Telemedicine was utilized more during months of heightened COVID-19 cases, with higher completion rates, fewer cancellations, shorter cycle times, saved travel distance, and comparable patient satisfaction to in-person visits. Telemedicine has the potential to remain an efficient mode of care delivery in the post-pandemic era.

Our objective was to create and evaluate a novel virtual platform dissection course to complement pediatric otolaryngology fellowship training in the setting of the COVID-19 pandemic.A four-station, four-simulator virtual course was delivered to pediatric otolaryngology fellows virtually using teleconferencing software. The four stations consisted of microtia ear carving, airway graft carving, cleft lip repair, and cleft palate repair. Fellows were asked to complete pre- and post-course surveys to evaluate their procedural confidence, expertise, and attitudes towards the course structure.Statistical analysis of pre-course survey data showed fellows agreed that simulators should play an important part in surgical training (4.59 (0.62)); would like more options for training with simulators (4.31 (0.88)); and would like the option of saving their simulators for later reference (4.41 (0.85)). Fellows found the surgical simulators used in the course to be valuable as potential training tools (3.96 (0.96)), as competency or evaluation tools (3.91 (0.98)), and as rehearsal tools (4.06 (0.93)). Analysis showed a statistically significant improvement in overall surgical confidence in performing all four procedures.This virtual surgical dissection course demonstrates 3D printed surgical simulators can be utilized to teach fellows advanced surgical techniques in a low-risk, virtual environment. Virtual platforms are a viable, highly-rated option for surgical training in the setting of restricted in-person meetings and as a mechanism to increase access for fellows by reducing costs and travel requirements during unrestricted periods.

Study Objectives Obstructive sleep apnea is associated with neurobehavioral dysfunction, but the relationship between disease severity as measured by the apnea-hypopnea index and neurobehavioral morbidity is unclear. The objective of our study is to compare the neurobehavioral morbidity of mild sleep-disordered breathing versus obstructive sleep apnea. Methods Children 3–12 years old recruited for mild sleep-disordered breathing (snoring with obstructive apnea-hypopnea index < 3) into the Pediatric Adenotonsillectomy Trial for Snoring were compared to children 5–9 years old recruited for obstructive sleep apnea (obstructive apnea-hypopnea 2–30) into the Childhood Adenotonsillectomy Trial. Baseline demographic, polysomnographic, and neurobehavioral outcomes were compared using univariable and multivariable analysis. Results The sample included 453 participants with obstructive sleep apnea (median obstructive apnea-hypopnea index 5.7) and 459 participants with mild sleep-disordered breathing (median obstructive apnea-hypopnea index 0.5). By polysomnography, participants with obstructive sleep apnea had poorer sleep efficiency and more arousals. Children with mild sleep-disordered breathing had more abnormal executive function scores (adjusted odds ratio 1.96, 95% CI 1.30–2.94) compared to children with obstructive sleep apnea. There were also elevated Conners scores for inattention (adjusted odds ratio 3.16, CI 1.98–5.02) and hyperactivity (adjusted odds ratio 2.82, CI 1.83–4.34) in children recruited for mild sleep-disordered breathing. Conclusions Abnormal executive function, inattention, and hyperactivity were more common in symptomatic children recruited into a trial for mild sleep-disordered breathing compared to children recruited into a trial for obstructive sleep apnea. Young, snoring children with only minimally elevated apnea-hypopnea levels may still be at risk for deficits in executive function and attention. Trial Registration Pediatric Adenotonsillectomy for Snoring (PATS), NCT02562040; Childhood Adenotonsillectomy Trial (CHAT), NCT00560859

Objectives The posterior cricoid split with rib graft is a procedure that elegantly corrects pediatric posterior glottic stenosis and subglottic stenosis. Currently, the procedure requires harvesting of rib cartilage which leaves room for optimization. With use of three dimensional printing technology, our objective was to design a device that would negate the need for costal cartilage harvesting in this procedure. Methods An optimized, novel polycaprolactone scaffold was designed using computer aided design software and three dimensional printing. A pilot proof of concept study was conducted with implantation of the device in three porcine animal subjects. Device was evaluated by post-procedural clinical course, endoscopic exams, post-mortem exam, and histological evaluation. Results A series of variably sized scaffolds were created. The scaffolds showed structural integrity and successfully expanded the cricoid cartilage in the porcine model study. Post-operative endoscopy and clinical exams demonstrated no signs of implant instability or failure. Gross and histologic exams showed successful mucosalization over the scaffold and cartilage ingrowth by six weeks. Conclusion This porcine animal pilot study demonstrated early success of a computer-aided designed, 3D printed, bioresorbable PCL posterior graft scaffold. The scaffolds eliminate the need for costal cartilage harvesting and had excellent surgical usability. The scaffolds functioned as designed, offering proof of concept and grounds for further evaluation to expand on this small pilot study with larger animal studies and continued design refinement.

Introduction Laryngotracheal reconstruction (LTR) with cartilage graft augmentation is an effective treatment for subglottic stenosis and a critical advanced procedure for Pediatric Otolaryngologists. Trainees almost exclusively learn this procedure intraoperatively on children due to the lack of adequate pediatric training models. An enhanced and accelerated educational experience may be possible if trainees can rehearse the key portions of the procedure on a simulation model. Objective To design and manufacture a low-cost, high fidelity surgical simulation model of subglottic stenosis for LTR. Methods This simulator is composed of two component models: rib cartilage and trachea. Additive manufacturing techniques, including Computer Aided Design and Three Dimensional (3D) printing, were utilized to create the simulator. Three expert Pediatric Otolaryngologists rated the functionality and realism of the simulator using Likert scale survey data. Results The use of CAD and 3D printing techniques allowed for realistic, reproducible surgical simulation of key aspects of LTR. The validation evidence indicated good to excellent means across the five domains relevant to the simulator's fidelity and usability (M = 3.47 to 4.00) out of a maximum of 4 points. Lowest rated items were consistent with expert comments suggesting minor simulator improvements. Time of production is approximately 20 h from print to post-processing, and consumable material costs per model are $2.60 USD. Conclusions This subglottic stenosis airway simulator facilitated Laryngotracheal Reconstruction rehearsal and is a promising training tool for pediatric otolaryngologists. Our methods allow patient-specific, pre-surgical rehearsal for complex airway scenarios that could benefit the experienced airway surgeon and trainees alike. Future research aims to validate this device's utility for accelerating attainment of proficiency and improving surgical outcomes.

Three-dimensional (3D) printing has transformed craniofacial reconstruction over the last 2 decades. For cutaneous oncologic surgeons, several 3D printed technologies are available to assist with craniofacial bony reconstruction and preliminary soft tissue reconstructive efforts. With improved accessibility and simplified design software, 3D printing has opened the door for new techniques in anaplastology. Tissue engineering has more recently emerged as a promising concept for complex auricular and nasal reconstruction. Combined with 3D printing, several groups have demonstrated promising preclinical results with cartilage growth. This article highlights the applications and current state of 3D printing and tissue engineering in craniofacial reconstruction.

Auricular reconstruction is a technically demanding procedure requiring significant surgical expertise, as the current gold standard involves hand carving of the costal cartilage into an auricular framework and re-implantation of the tissue. 3D-printing presents a powerful tool that can reduce technical demands associated with the procedure. Our group compared clinical, radiological, histological, and biomechanical outcomes in single- and two-stage 3D printed auricular tissue scaffolds in an athymic rodent model. Briefly, an external anatomic envelope of a human auricle was created using DICOM computed tomography (CT) images and modified in design to create a two-stage, lock-in-key base and elevating platform. Single- and two-stage scaffolds were 3D printed by laser sintering poly-L-caprolactone (PCL) then implanted subcutaneously in five athymic rats each. Rats were monitored for ulcer formation, site infection, and scaffold distortion weekly, and scaffolds were explanted at eight weeks with analysis using microCT and histologic staining. Nonlinear finite element analysis was performed to determine areas of high strain in relation to ulcer formation. Scaffolds demonstrated precise anatomic appearance and maintenance of integrity of both anterior and posterior auricular surfaces and scaffold projection, with no statistically significant differences in complications noted between the single- versus two-staged implantation. While minor superficial ulcers occurred most commonly at the lateral and superior helix coincident with finite element predictions of high skin strains, evidence of robust tissue ingrowth and angiogenesis was visible grossly and histologically. This promising preclinical small animal model supports future initiatives for making clinically viable options for an ear tissue scaffold.

Significance Algae live in association with microbes that interact by a variety of chemical mediators, resulting in mutualistic or antagonistic relationships. Although algae are key contributors to carbon fixation and are fundamental for food webs, we still know little about the underlying molecular mechanisms affecting their fitness. This study investigates the interaction between an antagonistic bacterium and a unicellular alga. It demonstrates multiple roles of a polyyne, protegencin, that is used by the bacteria to attack green algal cells. It is a highly effective toxin that alters a subcellular algal compartment used for vision, bleaches, and lyses the algal cells. These results expand our knowledge of the arsenal of chemical mediators in bacteria and their modes of action in algal communities., Algae are key contributors to global carbon fixation and form the basis of many food webs. In nature, their growth is often supported or suppressed by microorganisms. The bacterium Pseudomonas protegens Pf-5 arrests the growth of the green unicellular alga Chlamydomonas reinhardtii, deflagellates the alga by the cyclic lipopeptide orfamide A, and alters its morphology [P. Aiyar et al., Nat. Commun. 8, 1756 (2017)]. Using a combination of Raman microspectroscopy, genome mining, and mutational analysis, we discovered a polyyne toxin, protegencin, which is secreted by P. protegens, penetrates the algal cells, and causes destruction of the carotenoids of their primitive visual system, the eyespot. Together with secreted orfamide A, protegencin thus prevents the phototactic behavior of C. reinhardtii. A mutant of P. protegens deficient in protegencin production does not affect growth or eyespot carotenoids of C. reinhardtii. Protegencin acts in a direct and destructive way by lysing and killing the algal cells. The toxic effect of protegencin is also observed in an eyeless mutant and with the colony-forming Chlorophyte alga Gonium pectorale. These data reveal a two-pronged molecular strategy involving a cyclic lipopeptide and a conjugated tetrayne used by bacteria to attack select Chlamydomonad algae. In conjunction with the bloom-forming activity of several chlorophytes and the presence of the protegencin gene cluster in over 50 different Pseudomonas genomes [A. J. Mullins et al., bioRxiv [Preprint] (2021). https://www.biorxiv.org/content/10.1101/2021.03.05.433886v1 (Accessed 17 April 2021)], these data are highly relevant to ecological interactions between Chlorophyte algae and Pseudomonadales bacteria.

Objective The American Academy of Otolaryngology-Head and Neck Surgery Foundation's (AAO-HNSF's) 3D-Printed Temporal Bone Working Group was formed with the goal of sharing information and experience relating to the development of 3D-printed temporal bone models. The group conducted a multi-institutional study to directly compare several recently developed models. Study design Expert opinion survey. Setting Temporal bone laboratory. Methods The working group convened in 2018. The various methods in which 3D virtual models had been created and printed in physical form were then shared and recorded. This allowed for comparison of the advantages, disadvantages, and costs of each method. In addition, a drilling event was held during the October 2018 AAO-HNSF Annual Meeting. Each model was drilled and evaluated by attending-level working group members using an 15-question Likert scale questionnaire. The models were graded on anatomic accuracy as well as their suitability as a simulation of both cadaveric and operative temporal bone drilling. Results The models produced for this study demonstrate significant anatomic detail and a likeness to human cadaver specimens for drilling and dissection. Models printed in standard resin material with a stereolithography printer scored highest in the evaluation, though the margin of difference was negligible in several categories. Conclusion Simulated 3D temporal bones created through a number of printing methods have potential benefit in surgical training, preoperative simulation for challenging otologic cases, and the standardized testing of temporal bone surgical skills.

To assess the effect of 3-dimensional (3D)-printed surgical simulators used in an advanced pediatric otolaryngology fellowship preparatory course on trainee education.Quasi-experimental pre/postsurvey.Multicenter collaborative course conducted at a contract research organization prior to a national conference.A 5-station, 7-simulator prep course was piloted for 9 pediatric otolaryngology fellows and 17 otolaryngology senior residents, with simulators for airway graft carving, microtia ear framework carving, and cleft lip/palate repair. Prior to the course, trainees were provided educational materials electronically along with presurveys rating confidence, expertise, and attitude around surgical simulators. In October 2018, surgeons engaged in simulation stations with direction from 2 attending faculty per station, then completed postsurveys for each simulator.Statistically significant increases (We demonstrate the benefit of high-fidelity, 3D-printed simulators in exposing trainees to advanced procedures, allowing them hands-on practice in a zero-risk environment. In the future, we hope to refine this course design, develop standardized tools to assess their educational value, and explore opportunities for integration into use in milestone assessment and accreditation.

Background Pediatric-specific difficult airway guidelines include algorithms for 3 scenarios: unanticipated difficult tracheal intubation, difficult mask ventilation, and cannot intubate/cannot ventilate. While rare, these instances may require front-of-neck access (FONA) to secure an airway until a definitive airway can be established. The aim of this study was to develop a pediatric FONA simulator evaluated by both anesthesiology and otolaryngology providers, promoting multidisciplinary airway management. Methods A 3-dimensional-printed tracheal model was developed using rescaled, anatomically accurate dimensions from a computerized tomography scan using computer-aided design software. The medical grade silicone model was incorporated into a mannequin to create a low-cost, high-fidelity simulator. A multidisciplinary team of anesthesiology, otolaryngology, and simulation experts refined the model. Experts in airway management were recruited to rate the realism of the model's characteristics and features and their own ability to complete specific FONA-related tasks. Results Six expert raters (3 anesthesiology and 3 otolaryngology) were identified for multidisciplinary evaluation of model test content validity. Analysis of response data shows null variance within 1 or both specialties for a majority of the content validity tool elements. High and consistent absolute ratings for each domain indicate that the tested experts perceived this trainer as a realistic and highly valuable tool in its current state. Conclusions The ability to practice front-of-neck emergency airway procedures safely and subsequently demonstrate proficiency on a child model has great implications regarding both quality of physician training and patient outcomes. This model may be incorporated into curricula to teach needle cricothyroidotomy and other FONA procedures to providers across disciplines.

Background Current limitations in the supply of ventilators during the Covid19 pandemic have limited respiratory support for patients with respiratory failure. Split ventilation allows a single ventilator to be used for more than one patient but is not practicable due to requirements for matched patient settings, risks of cross-contamination, harmful interference between patients and the inability to individualize ventilator support parameters. We hypothesized that a system could be developed to circumvent these limitations. Methods and findings A novel delivery system was developed to allow individualized peak inspiratory pressure settings and PEEP using a pressure regulatory valve, developed de novo, and an inline PEEP ‘booster’. One-way valves, filters, monitoring ports and wye splitters were assembled in-line to complete the system and achieve the design targets. This system was then tested to see if previously described limitations could be addressed. The system was investigated in mechanical and animal trials (ultimately with a pig and sheep concurrently ventilated from the same ventilator). The system demonstrated the ability to provide ventilation across clinically relevant scenarios including circuit occlusion, unmatched physiology, and a surgical procedure, while allowing significantly different pressures to be safely delivered to each animal for individualized support. Conclusions In settings of limited ventilator availability, systems can be developed to allow increased delivery of ventilator support to patients. This enables more rapid deployment of ventilator capacity under constraints of time, space and financial cost. These systems can be smaller, lighter, more readily stored and more rapidly deployable than ventilators. However, optimizing ventilator support for patients with individualized ventilation parameters will still be dependent upon ease of use and the availability of medical personnel.

Nasal reconstruction frequently requires donor cartilage and tissue, and ideally, donor tissue will closely emulate native nasal cartilage mechanics. Tissue engineering scaffolds, especially 3D printed scaffolds, have been proposed for nasal reconstruction, and the success of these constructs may depend on how well scaffolds reflect native nasal cartilage mechanical properties. Therefore, consistent and comprehensive characterization of native nasal cartilage mechanical properties is a foundation for nasal cartilage tissue engineering and reconstruction in general by providing design targets for reconstructive materials. Our group has previously shown the feasibility of producing scaffolds with porous architecture permitting chondrocyte growth and cartilage production. In this study, we determined the nonlinear and stress relaxation behavior of human nasal cartilage under unconfined compression. We then fit this experimental data to nonlinear elastic, nonlinear viscoelastic and nonlinear biphasic constitutive models. The resulting coefficients will provide design targets for nasal reconstruction and scaffold design as well as outcome measures for assessment of tissue engineered nasal cartilage.

Background and Hypothesis: Protruding ears, also known as prominauris, are prevalent worldwide at an occurrence rate of about 5%. Children with prominauris report lower self-esteem and experience increased teasing and social isolation at school. From a functional standpoint, protruding ears can make wearing prescription glasses difficult. This increased stress and anxiety and impaired functionality lead children and families to seek treatment. One of the most effective treatments for protruding ears is otoplasty. This procedure involves an incision in the back of the ear and the placement of non-resorbable sutures to reform the ear. Alternatively, the procedure can be performed using an incisionless technique. As this is an elective procedure done commonly in children, adequate education of medical trainees is critical to ensure the proper level of skill is attained and patient satisfaction is maximized. Currently, teaching otoplasty is done with cadavers and supervised procedures with an attending. Surgical simulators are employed in the instruction of a variety of surgical procedures and allow residents to practice in a zero-risk environment. In addition, 3D printing has facilitated the development of surgical simulators allowing for a more cost-effective, consistent, and anatomically correct simulator. We developed an ear model made from silicone for trainees to practice traditional and incisionless otoplasty. Project Methods: The otoplasty surgical simulator was developed by isolating an ear from a computed-tomography scan in the Materialise software to create a 3D model. This model was then altered to create a negative mold. The mold was printed using fusion deposition printing with 1.75 MM polylactic acid filament. After printing, the mold was filled with Dragon Skin Silicone Shore 20 to simulate ear cartilage. The model was then coated in a layer of Dragon Skin Silicone Shore 10 to simulate a layer of skin. Conclusion and Potential Impact: This otoplasty simulator will next be validated by expert surgeons and then used in a surgical simulation workshop for surgical trainees. Because of the low-cost of the surgical simulator and the ease of manufacturing, this simulator can also be used to train surgeons abroad where access to surgical training may not be readily available.

Objectives/hypothesis Reconstruction of craniofacial cartilagenous defects are among the most challenging surgical procedures in facial plastic surgery. Bioengineered craniofacial cartilage holds immense potential to surpass current reconstructive options, but limitations to clinical translation exist. We endeavored to determine the viability of utilizing adipose-derived stem cell-chondrocyte co-culture and three-dimensional (3D) printing to produce 3D bioscaffolds for cartilage tissue engineering. We describe a feasibility study revealing a novel approach for cartilage tissue engineering with in vitro and in vivo animal data. Methods Porcine adipose-derived stem cells and chondrocytes were isolated and co-seeded at 1:1, 2:1, 5:1, 10:1, and 0:1 experimental ratios in a hyaluronic acid/collagen hydrogel in the pores of 3D-printed polycaprolactone scaffolds to form 3D bioscaffolds for cartilage tissue engineering. Bioscaffolds were cultured in vitro without growth factors for 4 weeks and then implanted into the subcutaneous tissue of athymic rats for an additional 4 weeks before sacrifice. Bioscaffolds were subjected to histologic, immunohistochemical, and biochemical analysis. Results Successful production of cartilage was achieved using a co-culture model of adipose-derived stem cells and chondrocytes without the use of exogenous growth factors. Histology demonstrated cartilage growth for all experimental ratios at the post-in vivo time point confirmed with type II collagen immunohistochemistry. There was no difference in sulfated-glycosaminoglycan production between experimental groups. Conclusion Tissue-engineered cartilage was successfully produced on 3D-printed bioresorbable scaffolds using an adipose-derived stem cell and chondrocyte co-culture technique. This potentiates co-culture as a solution for several key barriers to a clinically translatable cartilage tissue engineering process. Level of evidence NA. Laryngoscope, 128:E251-E257, 2018.

Objective To describe changes in diet and swallow function in patients with a laryngeal cleft after surgical repair of the laryngeal cleft. Methods Retrospective case series performed using chart review. Primary outcomes were diet and swallow function before and after laryngeal cleft repair. Clinical evaluation and video fluoroscopic swallow studies (VFSS) were used to assess pre- and post intervention swallowing. Results 16 pediatric patients were included in this study. Preoperatively, 14 (88%) patients had diet restrictions. Postoperatively, 12 (75%) patients tolerated a regular diet without limitation. 4 (25%) patients had no reduction in diet restrictions over the course of this study. For the 10 patients who transitioned to a regular diet postoperatively, a median of 300 days (range: 26 days - 3 years) passed to document achieving a regular diet. This was corroborated by an increase in normal oral and pharyngeal phase swallow function on VFSS postoperatively when compared with preoperative VFSS results. Conclusion Dysphagia improves in most patients after laryngeal cleft repair. The range in time to a normal diet was wide. This may facilitate improved preoperative counseling and preparation of families' expectations.

This study proposes and evaluates a physical cleft lip repair simulator for trainee education.

Autologous cartilage grafting during open airway reconstruction is a complex skill instrumental to the success of the operation. Most trainees lack the adequate opportunity to develop proficiency in this skill. We hypothesized three-dimensional (3D) printing and computer-aided design can be used to create a high-fidelity simulator for developing skills carving costal cartilage grafts for airway reconstruction. The rapid manufacturing and low cost of the simulator allow deployment in locations lacking expert instructors or cadaveric dissection, such as medical missions and third world countries. In this blinded, prospective observational study resident trainees completed a physical simulator exercise using a 3D-printed costal cartilage grafting tool. Participant assessment was performed using a Likert-scale questionnaire and airway grafts were assessed by a blinded expert surgeon. A majority of participants found this to be a very relevant training tool and highly rated the level of realism of the simulation tool.

Aggressive fibromatosis is an uncommon, benign tumor of fibroblastic origin with high potential for local invasion. Less than a quarter of these lesions are located in the head and neck, and although extremely rare, associations have been demonstrated with physical trauma. We describe a unique case of oropharyngeal fibromatosis with traumaticetiology, managed successfully with surgical excision of the lesion with negative surgical margins. A 5-year old patient was found to have an aggressive fibromatosis causing oropharyngeal stenosis following tonsillectomy. We demonstrate that surgical resection with a clear margin allowed for alleviation of stenosis without recurrences reported since the procedure.

IMPORTANCE: Facial flap procedures may be difficult for surgical trainees to conceptualize and challenging for supervising surgeons to allow entrustment early in training. Simulation outside of the operating room may accelerate and enhance the surgical education experience. OBJECTIVE: To design and manufacture a 3-dimensional (3-D)–printed, multilayer, anatomically accurate facial flap model for use in surgical education. DESIGN, SETTING, AND PARTICIPANTS: In this multicenter validation study, a 3-D–printed facial flap simulator was designed from a computed tomographic (CT) scan and manufactured for low-cost, high-fidelity simulation. Expert otolaryngology–head and neck surgeon feedback was acquired through surgical rehearsal and performance of 8 local facial flap procedures on the facial flap simulator by 7 otolaryngologists fellowship trained in facial plastic surgery. MAIN OUTCOMES AND MEASURES: Likert scale surveys were made based on evaluation criteria categorized into domains of realism, experience, and applicability of the simulator. Measures of central tendency, variability, and confidence intervals were generated to evaluate the outcomes. RESULTS: Seven expert otolaryngology–head and neck surgeons completed a Likert scale evaluation survey containing quantitative analysis of 6 questions on physical attributes, 12 questions on realism, 8 questions on experience, and 4 questions on the applicability of the simulator. All expert surgeons were additionally fellowship trained in facial plastic surgery with their mean years in practice being 11.9. Overall evaluation demonstrated valuable ability of the simulator for medical education with suggestions for future directions. Importantly, the simulator was rated on a scale of 1 (no value) to 4 (great value) as 3.86 as a training tool, 3.57 as a competency evaluation tool, and 3.43 as a rehearsal tool. CONCLUSIONS AND REVELANCE: Expert experience with the local facial flap simulator was rated highly for realism, experience, performance, and usefulness. With slight refinement, the model has strong potential for broad use in training in otolaryngology–head and neck surgery and facial plastic surgery. LEVEL OF EVIDENCE: NA.

Introduction Micrognathia, a component of Robin Sequence, can cause glossoptosis, failure of palatal fusion, and critical obstruction of the airway. Mandibular distraction osteogenesis (MDO) is at times offered to anteriorly translate the mandible and tongue, relieving airway obstruction. MDO is an intricate reconstructive procedure that may be ideal for teaching using a high-fidelity educational simulator, allowing early hands-on experience in a zero-risk environment. Objectives To design a novel, low-cost, high-fidelity neonatal MDO simulator that can be used for trainee education and refinement of surgical technique. Methods A novel MDO simulator was developed using additive manufacturing techniques. Three experts in MDO surgery completed a 20-item survey, rating the simulator's physical attributes, the realism of experience, the simulator's value, its relevance to practice and the surgeon's ability to perform tasks on a 4-point Likert scale. Results Computer Aided Design (CAD) and 3D printing allowed for the production of a realistic surgical simulator that emulates important aspects of MDO surgery. This preliminary evaluation indicated adequate means across the five domains relevant to the simulator's fidelity and usability (M = 3.33 to 3.75) out of a maximum of 4 points. Lowest rated items were consistent with expert comments allowing future refinement on subsequent iterations. Consumable material costs per model were $9.39 USD. Conclusions The MDO model demonstrated adequate fidelity and holds promise as a skill-development tool for surgeons in training. Further studies are planned to determine its utility as a training and assessment tool.

IntroductionMild obstructive sleep-disordered breathing (oSDB), characterised by habitual snoring without frequent apnoeas and hypopnoeas on polysomnography, is prevalent in children and commonly treated with adenotonsillectomy (AT). However, the absence of high-level evidence addressing the role of AT in improving health and behavioural outcomes has contributed to significant geographical variations in care and potential for surgery to be both overused and underused.Methods and analysisThe Pediatric Adenotonsillectomy Trial for Snoring (PATS) is a single-blinded, multicentre randomised controlled trial designed to evaluate the effect of AT in treating mild oSDB. Four hundred sixty eligible children, aged 3.0–12.9 years old, will be randomised to either early adenotonsillectomy or to watchful waiting with supportive care (WWSC) with a 1:1 ratio. The study’s coprimary endpoints are (1) change from baseline in executive behaviour relating to self-regulation and organisation skills as measured by the Behavioural Rating Inventory of Executive Function (BRIEF) Global Composite Score (GEC); and (2) change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d-prime). A mixed effects model will be used to compare changes in the BRIEF GEC score and GNG score at 6 and 12 months from baseline between the AT arm and the WWSC arm.Ethics and disseminationThe study protocol was approved by the institutional review board (IRB) at Children’s Hospital of Philadelphia (CHOP) on 3 October 2014 (14–0 11 214). The approval of CHOP as the central IRB of record was granted on 29 February 2016. The results will be published in peer-reviewed journals and presented at academic conferences. The data collected from the PATS study will be deposited in a repository (National Sleep Research Resource, sleepdata.org) after completion of the study to maximise use by the scientific community.Trial registration numberNCT02562040; Pre-results.

The specialty of otolaryngology-head and neck surgery comprises surgery of the craniofacial composition, ear, nose, throat, neck, and airway. Within this specialty, there are several clinical conditions that lack an ideal treatment. For these challenges, current techniques exhaust the demand and often fall short of the level of precision and customization that are necessary for satisfactory outcomes. Additive manufacturing and bioprinting provide paradigm-shifting potential for treatment options exceeding prior standard therapies. In this chapter, we describe the current state of clinically challenging conditions that have set the stage for applications of additive manufacturing and bioprinting. To date, application of additive manufacturing for airway and facial reconstruction can be generally grouped into (1) scaffold-based engineering guiding native tissues, (2) cell-seeded scaffolds, and (3) cell or hydrogel deposition printing.

Background Similar to other sub-Saharan countries, Ethiopia suffers from a severe shortage of adequately trained health professionals. Academic partnerships can support sustainable training programs and build capacity for low-resource settings. 3D modeling and simulation-based training provide necessary tools, especially for rarely-encountered clinical situations, such as needle cricothyroidotomy. Methods Departments of Anesthesiology, Otolaryngology, and Learning Health Sciences collaborated to develop a low-cost, high-fidelity simulator and Cricothryoidotomy Skills Maintenance Program (CSMP). Twelve anesthesia residents at St. Paul's Hospital Medical Millennium College in Addis Ababa, Ethiopia participated in CSMP. The program consisted of a didactic session with presentation and demonstration and an immersive CICO scenario. Program evaluation was performed using pre/post-training knowledge and 2 procedural performance assessments-the CSMP Global Rating Scale and the Checklist. With consent, performances were videotaped and rated independently by 3 University of Michigan faculty. Results Improvements were identified in all areas, including residents' knowledge, measured by mean summed test scores (Mpre = 3.31,Mpost = 4.46,p = 0.003), time to perform cricothyroidotomy (Mpre = 96.64,Mpost = 72.82,p = 0.12), residents' performance quality, measured by overall mean Global ratings, (Mpre = 0.20; Mpost = 0.70) with improvements identified at the item-level, p = 0.001 with moderate-large effect sizes, and residents' ability to complete tasks, measured by mean Checklist ratings (Mpre = 0.51,Mpost = 0.90, with item-level improvements observed, p ≤ 0.01, with small-large effect sizes. Residents' self-reported confidence also improved (Mpre = 1.69, Mpost = 3.08,p = 0.001). Conclusion Our work shows that cricothyroidotomy skills taught to anesthesia residents at SPHMMC with a 3D printed laryngotracheal model improves knowledge, skills, and confidence. The creation of a low-cost, high-fidelity simulator and a CSMP has the potential to impact patient care and safety world-wide.

A 16-year-old boy with Chiari 1 malformation presented for an elective suboccipital craniectomy and C1 laminectomy. His intraoperative course was uneventful. At the conclusion of the procedure, he met extubation criteria and followed commands. After extubation, he developed progressive upper airway obstruction and became obtunded. He was reintubated via videolaryngoscopy, which showed edema not only to the tongue, but also to the posterior pharynx and blisters over the vocal folds and epiglottis. The patient was transferred to the pediatric intensive care unit intubated and sedated. This report describes the clinical course of his massive macroglossia and discusses short- and long-term management.

Objective This study aims to determine the effect of auricular scaffold microarchitecture on chondrogenic potential in an in vivo animal model. Methods DICOM computed tomography (CT) images of a human auricle were segmented to create an external anatomic envelope. Image-based design was used to generate 1) orthogonally interconnected spherical pores and 2) randomly interspersed pores, and each were repeated in three dimensions to fill the external auricular envelope. These auricular scaffolds were then 3D printed by laser sintering poly- l -caprolactone, seeded with primary porcine auricular chondrocytes in a hyaluronic acid/collagen hydrogel and cultured in a pro-chondrogenic medium. The auricular scaffolds were then implanted subcutaneously in rats and explanted after 4 weeks for analysis with Safranin O and Hematoxylin and Eosin staining. Results Auricular constructs with two micropore architectures were rapidly manufactured with high fidelity anatomic appearance. Subcutaneous implantation of the scaffolds resulted in excellent external appearance of both anterior and posterior auricular surfaces. Analysis on explantation showed that the defined, spherical micropore architecture yielded histologic evidence of more robust chondrogenic tissue formation as demonstrated by Safranin O and Hematoxylin and Eosin staining. Conclusions Image-based computer-aided design and 3D printing offers an exciting new avenue for the tissue-engineered auricle. In early pilot work, creation of spherical micropores within the scaffold architecture appears to impart greater chondrogenicity of the bioscaffold. This advantage could be related to differences in permeability allowing greater cell migration and nutrient flow, differences in surface area allowing different cell aggregation, or a combination of both factors. The ability to design an anatomically correct scaffold that maintains its structural integrity while also promoting auricular cartilage growth represents an important step towards clinical applicability of this new technology.