Abstract
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 3D 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, 3 otolaryngology) were identified for multidisciplinary evaluation of model test content validity. Analysis of response data shows null variance within one 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.
Conclusion:
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.
Introduction:
Front of neck access (FONA) emergency airway procedures are infrequently required, yet these are critical skills for physicians responsible for responding to difficult airway situations. The incidence of a “Cannot Intubate, Cannot Oxygenate” (CICO) scenario is low in the pediatric population1,2, and the incidence of required needle cricothyroidotomy is not reported. Despite this, FONA procedures including needle cricothyroidotomy are required as the terminal step of the pediatric difficult airway algorithm.3 Limited performance of cricothyroidotomy and FONA procedures may be in part due to lack of familiarity and comfort.
Procedural training in the pediatric population poses several challenges and opportunities uniquely suitable for 3-Dimensional (3D) printing. There are virtually no opportunities to practice techniques on pediatric cadaveric models, and there is a paucity of high-fidelity, advanced procedural task trainers. Improvements in 3D printing technology, precise anatomic image based computer aided design, and materials advancements have resulted in our group’s ability to develop simulation trainers with high visual and anatomic fidelity, realistic tissue dynamics, and affordable replaceable parts.4–6
We identified a need for training of pediatric providers in FONA procedures based on low reported experience and an institutional shift toward use of a Ravussin catheter cricothyroidotomy technique, favored over traditional needle cricothyroidotomy. This technique uses an angulated needle stylet and catheter that can be readily attached to conventional resuscitation equipment (airway circuit or bag) or a high-pressure oxygen source by a luer-lock fitting, and can be inserted atraumatically with the connector sitting flush with the front of neck.7 Validated task trainers for this skill do not exist, and evaluation of validity evidence of a model for this technique is challenging due to infrequent and unpredictable nature of the task.
Building on over ten years of institutional experiences using 3D printing for medical applications and simulation, our group developed a pediatric airway task trainer which incorporates a high fidelity, 3D-printed pediatric tracheal model embedded into a low-cost pediatric head and neck model.8 Expert evaluators were sought from anesthesiology and otolaryngology specialties, as both teams are involved in pediatric emergent airway management.
The aim of this study is to describe the development of the task trainer, as well as report multidisciplinary evidence of content validity from experienced practitioners in both fields of anesthesiology and otolaryngology, who ultimately will be responsible for responding to pediatric difficult airway situations. Indeed, the ability to practice advanced procedures safely and subsequently demonstrate proficiency on a child model has great implications regarding both quality of physician training and patient outcomes.
Methods:
Computer Aided Design, 3D Printing, and Creation of Task Trainer
Following IRB approval, a 3D representation of the trachea was designed using computer aided design (CAD) software (Materialise, Plymouth MI) from a high resolution 0.75 mm CT scan. The anatomy approximated the size of a 5-year-old patient. The molding system included a combination of external casing and an internal insert to allow for a patent airway and 3D printed using fused deposition modeling techniques in polylactic acid. Medical grade 45 shore silicone was molded and cured at 60 degrees Celsius for 6 hours. Upon completion, the tracheal model was removed from the mold system and embedded in a pediatric head and neck model that was milled to include a hyoid bone. (Figure 1). The model was overlaid with synthetic skin (One World DMG Ltd, Warren NJ) to allow a realistic outer neck appearance, manual palpation of laryngeal landmarks, and performance FONA task (needle cricothyroidotomy using Ravussin catheter technique, Figure 2).
Figure 1. Computer Aided Design and Task Trainer.
(A) Computer aided design of pediatric tracheal model based on CT scan. (B) Medical grade silicone model, and (C) model inserted into mannequin with external skin covering removed to show position and landmarks.
Figure 2.
Front of Neck Access Task Trainer, Procedural Use. (A, inset left) Ravussin catheter equipment: Needle stylet, catheter sheath with airway circuit connector, velcro ties, and ventilation tubing. (B, top) Task trainer and endoscopic view of tracheal lumen. (C, bottom) Inserted Ravussin catheter and confirmed placement within airway.
Evidence of Content Validity
The FONA task trainer content validity form was developed to capture expert faculty opinion toward specific features and characteristics of the model using a process established in previous work.9,10 The final tool was reviewed and approved by a multidisciplinary team of specialists in fields of anesthesiology, otolaryngology, and clinical simulation. The content validity form included measures of demographics targeting participants’ experience and skill with managing difficult airway, perceived value of the simulator, and self-reported ability to perform the FONA task using the trainer (Supplemental 1). Measures of content validity included 23 items representing one domain of “Ability” (Ability to perform tasks) and 4 domains of “Value”: a) Visual attributes, b) Realism of materials, c) Realism of experience and d) Value of tool. Additional single-item measures included Relevance of simulator to practice, Comparison of the Ravussin catheter technique to standard needle cricothyroidotomy, and Global/overall value.
Domains of Visual attributes, Realism of materials, and Realism of experience were scored using 4-point rating scales with anchors 1 (Not at all realistic), 2 (Lacks key features that require improvement), 3 (Adequate realism as is, but could be improved slightly), and 4 (Highly realistic, no changes needed). The Value as tool domain was also scored using 4-point rating scales, but anchored as 1 (No value), 2 (Little value), 3 (Some value), and 4 (High value). Ability to perform tasks (Ability) was broken down into 8 discrete steps of the procedure, each scored using 5-point rating scales anchored as 1 (Too difficult to perform), 2 (Difficult to perform), 3 (Reasonably difficult to perform), 4- (Easy to perform), and 5 (Very easy to perform). Relevance to practice was scored as 1 (No relevance), 2 (Little relevance), 3 (Some relevance), and 4 (Great relevance). Comparison of Ravussin to standard technique was scored on a 5-point scale, and anchored as 1 (Much harder), 2 (Somewhat harder), 3 (About the same), 4 (Somewhat easier), and 5 (Much easier). The Global rating item was scored on a four-point rating scale, ranging from (1) “This simulator requires a number of improvements before it can be considered for needle cricothyroidotomy training” to (4) “This simulator can be considered for needle cricothyroidotomy training with no improvements needed.”
Physician with expertise in pediatric airway management were identified to perform a FONA procedure (Ravussin catheter insertion) using the task trainer, and responses regarding demographics, Value, Ability, and global measures were recorded using the content validity form described above. Expert raters were selected as attending physicians who were fellowship trained in pediatric anesthesiology, pediatric otolaryngology, laryngology or airway reconstruction, such that each had clinical expertise in airway management and front of neck access procedures, including needle cricothyroidotomy and/or tracheostomy.
Statistical Analysis
Validity evidence relevant to test content was evaluated using current Standards framework.11 Mean ratings for each domain, and for each of the 26 items (23 within domains, 3 single-item) indicates the respondents’ combined averaged ratings for each specialty. Higher observed means suggest high perceived value for that particular feature or characteristic of the simulator, while lower observed means suggest lower perceived value. Comparison was further performed by anesthesiologist versus otolaryngologist groups. Distribution of responses and descriptive statistics are presented.
Results:
Participants.
Six faculty physicians experienced in emergent airway management (anesthesiology n=3, otolaryngology n=3) participated in the study. All participating faculty self-reported themselves as “very skilled” in direct laryngoscopy, intubation, and at least one form of front of neck access. Varying levels of practical experience in front of neck procedures was reported, with otolaryngologists reporting higher skill levels with surgical access via tracheostomy. All participants indicated professional responsibility to perform tasks including bag mask ventilation, direct laryngoscopy, awake fiberoptic intubation, and either cricothyroidotomy (5/6 participants) or open tracheostomy (all otolaryngology faculty, no anesthesia faculty). Data were generated from rater responses to the content validity form following FONA task performance using the described task trainer (Figures 1 & 2).
Simulator fidelity.
In descending order, mean “Value” domain ratings were calculated to be 4.00 (Value as tool), 4.00 (Relevance to practice), 3.83 (Global), 3.53 (Realism of experience), 3.39 (Visual attributes), and 3.28 (Realism of materials) (Table 1). Mean Ability to perform tasks was reported as 4.22 on a 5-point scale. Examination of rating differences at the item-level indicated no significant differences for all items of the following “Value” domains–Visual attributes, Realism of materials, Value as tool, and Relevance to practice. Despite rating differences associated with Realism of experiences, the mean of the Global Value opinion ratings was high for both anesthesiology (M=4.00) and otolaryngology (M=3.67) faculty. This indicates that all participants agreed the simulator could be considered for training in the current state, with possibility for slight improvements. Finally, examination of rating differences at the item-level indicated similar scores for all Ability items. Differences were appreciated between disciplines for just three elements, including Force required to insert needle, Trajectory required to insert needle, and Advancement of catheter, which may be related to differential expectations based on practice pattern, discussed below.
Table 1.
Content Validity Tool Mean Ratings
| Item No. | Domain/Characteristic | Anesthesia Mean (n=3) | Otolaryngology Mean (n=3) | Combined Mean (n=6) |
|---|---|---|---|---|
| Visual Attributes (4-point scale) | 3.20 (0.56) | 3.58 (0.64) | 3.39 (0.62) | |
| 1 | Size of model (4–5 year old child) | 3.33 (0.58) | 3.67 (0.58) | 3.50 (0.55) |
| 2 | Appearance, external neck | 3.00 (0.00) | 3.33 (0.58) | 3.16 (0.41) |
| 3 | Landmark, feel of cricoid cartilage | 3.00 (0.00) | 3.00 (1.41) | 3.00 (0.71) |
| 4 | Landmark, feel of thyroid cartilage | 3.33 (0.58) | 3.67 (0.58) | 3.50 (0.55) |
| 5 | Landmark, feel of trachea | 3.33 (0.58) | 4.00 (0.00) | 3.67 (0.82) |
| Realism of Materials (4-point scale) | 3.33 (0.50) | 3.22 (0.67) | 3.28 (0.57) | |
| 6 | Lifelike feel of external neck skin | 3.00 (0.00) | 3.00 (0.00) | 3.00 (0.63) |
| 7 | Lifelike feel of laryngeal cartilages | 3.67 (0.58) | 3.33 (0.58) | 3.50 (0.55) |
| 8 | Lifelike feel of cricothyroid membrane/puncture | 3.33 (0.58) | 3.33 (0.58) | 3.33 (0.52) |
| Realism of Experience (4-point scale) | 3.87 (0.36) | 3.17 (0.58) | 3.53 (0.58) | |
| 9 | Using laryngeal cartilages to guide puncture in cricothyroid membrane | 3.67 (0.58) | 3.33 (0.58) | 3.50 (0.55) |
| 10 | Force required to insert needle | 4.00 (0.00) | 3.00 (0.00) | 3.50 (0.84) |
| 11 | Trajectory required to insert needle | 4.00 (0.00) | 3.33 (0.58) | 3.67 (0.52) |
| 12 | Advancement of catheter | 4.00 (0.00) | 3.00 (0.00) | 3.50 (0.55) |
| 13 | Initiating ventilation through catheter | 3.50 (0.71) | 3.67 (0.58) | 3.50 (0.71) |
| Ability to perform tasks (5-point scale) | 3.87 (0.36) | 3.17 (0.58) | 4.22 (0.72) | |
| 14 | Palpate cricoid cartilage | 3.67 (0.58) | 4.67 (0.58) | 4.17 (0.75) |
| 15 | Palpate thyroid cartilage | 3.67 (0.58) | 4.67 (0.58) | 4.17 (0.75) |
| 16 | Identify Ravussin catheter entry point at the cricothyroid membrane | 3.33 (1.53) | 4.67 (0.58) | 4.00 (1.26) |
| 17 | Insertion of needle | 4.33 (0.58) | 4.67 (0.58) | 4.50 (0.55) |
| 18 | Advancement of catheter | 4.00 (1.00) | 4.00 (0.00) | 4.00 (0.63) |
| 19 | Confirm placement in the airway lumen | 4.00 (1.00) | 4.33 (0.58) | 4.17 (0.75) |
| 20 | Remove needle with catheter in place | 4.33 (0.58) | 4.33 (0.58) | 4.33 (0.52) |
| 21 | Attach ventilation system | 4.33 (0.58) | 4.50 (0.71) | 4.40 (0.55) |
| Value (4-point scale) | 4.00 (0.00) | 4.00 (0.00) | 4.00 (0.00) | |
| 22 | As training tool | 4.00 (0.00) | 4.00 (0.00) | 4.00 (0.00) |
| 23 | As testing/assessment tool | 4.00 (0.00) | 4.00 (0.00) | 4.00 (0.00) |
| Relevance (4-point scale) | ||||
| 24 | Relevance of simulator to practice | 4.00 (0.00) | 4.00 (0.00) | 4.00 (0.00) |
| Comparison, Ravussin to Needle Cricothyroidotomy (5 point scale) | ||||
| 25 | How does Ravussin technique compare to standard | 4.00 (1.00) | 5.00 (0.00) | 4.50 (0.84) |
| Global (4-point scale) | ||||
| 26 | Overall value | 4.00 (0.00) | 3.67 (0.58) | 3.83 (0.41) |
Overall, Otolaryngologists and Anesthesiologists did not show significant differences in responses. Little variance was seen between groups, with 14 items showing null variance, indicated by standard deviation equal to zero within one or both groups.
Discussion:
Development of Task Trainer
The first difficult airway management algorithm was introduced by the American Society of Anesthesiologists (ASA) in 1993; however, it wasn’t until 2012 that pediatric-specific algorithms were released as a joint effort by the Difficult Airway Society UK and the Association of Paediatric Anaesthetists.3,12,13 According to these guidelines, FONA is the final common pathway for life-threatening Cannot-Intubate-Cannot-Oxygenate (CICO) scenarios. While this study tested needle cricothyroidotomy via Ravussin catheter technique7, FONA procedures may also include scalpel-bougie technique or open tracheostomy. Choice of procedure in emergent airway setting varies and depends on personnel, available equipment, and specific clinical scenario. Further standardization of equipment, techniques and training has been proposed.14 For successful outcomes in emergency scenarios, having baseline knowledge is critical, and improved outcomes have been shown through rehearsing emergent situations within an algorithm.3,15 Thus, a validated, simulation-based performance measures for FONA procedures is exceedingly necessary.
Our model was developed by a team with overlapping professional experience in anesthesiology, otolaryngology, and medical education. Surgical airway simulators employing the use of 3D printing for endolaryngeal or open airway procedures have previously been described in otolaryngology.4,5,16 We feel that the successful design and manufacturing of this model is dependent on strong institutional support, availability of resources and the authors’ experience within the field of 3D printing. While the time, resources, and technical expertise required to design and generate the 3D printed cast for this model were substantial, the medical grade tracheal models used in this study have an estimated raw materials cost of $2.86. Further, the nature of the simulator materials allows for numerous needle cricothyroidotomy repetitions with negligible wear and significant longevity adding further value as a training tool. Furthermore, our rapid manufacturing techniques would allow for inclusion of different sized models for different ages, and a variety of airway pathologies, such as subglottic stenosis, and even readily facilitate simulation of challenging patient-specific scenarios.
Validity Evidence
All items met a minimum criterion of 3.0, indicating that all expert raters felt the model was appropriate for use in its current state, though could benefit from minor modifications. Recommendations included modifying the resistance required to insert the needle/catheter and making the neck extendable; however, these comments were not universally reported and the latter could not be practically implemented without significantly adding cost. Importantly, scores of Value as a training tool, Value as an educational tool, and Relevance to practice were uniformly reported as 4.0/4.0, indicating unanimous sense of great potential of this model for use to train clinical practitioners.
Discrepancies indicated by higher relative variability in ratings across groups were considered for 3 out of 5 items within the Realism of experiences domain, including Force required to insert needle, Trajectory required to insert needle, and Advancement of catheter elements. For these features, otolaryngologists reported lower realism of experience than anesthesiologists. These discrepancies may be related to differences in haptic experiences when performing landmark evaluation for intubation and routine airway management (anesthesiology) versus performing open tracheostomy or airway reconstruction (otolaryngology). As Ravussin catheter insertion and traditional needle cricothyroidotomy are not open procedures, the anesthesiologist perspective may be of more value for this specific use.
Our study found that the expert raters felt the Ravussin catheter technique was easier to perform than a traditional needle cricothyroidotomy (mean=4.5, anchor 4= “somewhat easier”, 5= “much easier”). Even so, with recent shift toward Ravussin catheter as the preferred technique at our institution, providers have reported deficient familiarity with the equipment and procedural steps of this technique. Taken together, this highlights a strength that a validated task trainer could facilitate training of both standard and novel techniques in a safe environment.
Limitations and Future Directions
The most notable limitation of this study was small sample size. This is concordant with the low number of providers who may be considered true experts for emergent pediatric needle cricothyroidotomy. The expert raters in this study were chosen based on significant airway management expertise. Testing multiple disciplines involved in pediatric airway management both increased the pool of available experienced participants and provided varying professional perspectives which the authors feel adds considerable value to the study.
An additional limitation of this preliminary study is the scope of validity evidence, which was limited to evidence relevant to test content and internal structure. It did not include evidence relevant to response process, relationships to other variables or consequences of testing.
Thus, a logical step following this preliminary validation of this task trainer is implementation of the model in a training curriculum, within and outside of our institution, to evaluate the model’s value in a training program. Future studies will benefit from other participating fields that including Emergency Medicine, Critical Care, and Emergency Medical Technicians, many of whom will encounter scenarios where ability to perform emergent FONA procedures would be life-saving.
Such portable and low-cost models are amenable to traditional didactic, competency-based curricula, and those employing a self-guided or mastery of learning model.17–20 In this context, a simulation-based curriculum using the proposed model may be used to train providers of various disciplines involved in pediatric airway management, with potential utility for demonstration of proficiency, initial certification, and maintenance of certification. Finally, our group has proposed use of this model as a global training tool which could be used to teach pediatric airway procedures in low, middle, and high resource settings. High-fidelity and low-cost of the model have allowed practical dissemination and implementation of such global initiatives by our team.21
Conclusion:
Pediatric front of neck access is a rarely performed life-saving skill that can be critical to successful airway management when required in urgent and emergent settings. This skill is particularly suitable to simulation training, giving providers the ability to practice airway procedures safely on a realistic pediatric model and subsequently demonstrate and maintain proficiency. This model may be incorporated into educational curricula to teach needle cricothyroidotomy and other FONA procedures to practitioners across multiple disciplines responsible for airway management.
Supplementary Material
Key Points Summary:
Question:
The aim of this study was to develop and evaluate preliminary validity evidence of a task trainer for pediatric front of neck access procedures.
Findings:
The described 3D-printed task trainer is a low-cost, high-fidelity model supported by multidisciplinary preliminary validity evidence, making it a practical and valuable tool for procedural education.
Meaning:
This model can be incorporated into curricula to develop proficiency and ensure mastery of needle cricothyroidotomy and other airway procedures across disciplines, at institutional, national, and international stages.
Acknowledgements:
The authors would like to thank the faculty who participated in this study as evaluators: Elizabeth Putnam, MD; Paul Reynolds, MD; Prabhat Koppera, MD; Glenn Green, MD; Keith Casper, MD; and Robbi Kupfer, MD. The authors appreciate support from the University of Michigan Clinical Simulation Center Research Grant (all authors), as well as NIH training grant T32 DC005356 (K.J.K, A.R.P. and C.L.R.).
Funding: Authors K.J.K, A.R.P., and C.L.R. are supported by NIH grant T32 DC005356 (T32 Training Grant). This work is supported by a Research Grant funded by the University of Michigan Clinical Simulation Center.
Footnotes
Conflicts of Interests/Financial Disclosures: None
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