Objectives/Hypothesis Evaluate technical success, tolerability, and safety of lidocaine iontophoresis and tympanostomy tube placement for children in an office setting. Study Design Prospective individual cohort study. Methods This prospective multicenter study evaluated in‐office tube placement in children ages 6 months through 12 years of age. Anesthesia was achieved via lidocaine/epinephrine iontophoresis. Tube placement was conducted using an integrated and automated myringotomy and tube delivery system. Anxiolytics, sedation, and papoose board were not used. Technical success and safety were evaluated. Patients 5 to 12 years old self‐reported tube placement pain using the Faces Pain Scale–Revised (FPS‐R) instrument, which ranges from 0 (no pain) to 10 (very much pain). Results Children were enrolled into three cohorts with 68, 47, and 222 children in the Operating Room (OR) Lead‐In, Office Lead‐In, and Pivotal cohorts, respectively. In the Pivotal cohort, there were 120 and 102 children in the <5 and 5‐ to 12‐year‐old age groups, respectively, with a mean age of 2.3 and 7.6 years, respectively. Bilateral tube placement was indicated for 94.2% of children <5 and 88.2% of children 5 to 12 years old. Tubes were successfully placed in all indicated ears in 85.8% (103/120) of children <5 and 89.2% (91/102) of children 5 to 12 years old. Mean FPS‐R score was 3.30 (standard deviation [SD] = 3.39) for tube placement and 1.69 (SD = 2.43) at 5 minutes postprocedure. There were no serious adverse events. Nonserious adverse events occurred at rates similar to standard tympanostomy procedures. Conclusions In‐office tube placement in selected patients can be successfully achieved without requiring sedatives, anxiolytics, or papoose restraints via lidocaine iontophoresis local anesthesia and an automated myringotomy and tube delivery system. Level of Evidence 2b Laryngoscope, 130:S1–S9, 2020
Poster Presentations P159 POSTERSimaging, Wii Fit pressure pad for tracing the center of gravity, and Unity game engine for leveled-difficulty design. Five VR tasks were built, and more than 100 training trials were designed. Subjectively, all patients experienced the improvement of balance function performing daily activities and were overall positive to the training protocol. After intervention the fast component of postural sway (P < .05) was reduced. The follow-up interview showed decreased disability and increased general health.Conclusion: VR has many advantages over traditional rehabilitation techniques in improving the testing or training environment of human performance. This study demonstrates that VR technology offers great promise in the field of vestibular rehabilitation.
ObjectiveEvaluate 2‐year outcomes after lidocaine/epinephrine iontophoresis and tympanostomy using an automated tube delivery system for pediatric tube placement in‐office.Study DesignProspective, single‐arm.SettingEighteen otolaryngology practices.MethodsChildren age 6 months to 12 years indicated for tympanostomy were enrolled between October 2017 and February 2019. Local anesthesia of the tympanic membrane was achieved via lidocaine/epinephrine iontophoresis and tympanostomy was completed using an automated tube delivery system (the Tula® System). An additional Lead‐In cohort of patients underwent tube placement in the operating room (OR) under general anesthesia using only the tube delivery system. Patients were followed for 2 years or until tube extrusion, whichever occurred first. Otoscopy and tympanometry were performed at 3 weeks, and 6, 12, 18, and 24 months. Tube retention, patency, and safety were evaluated.ResultsTubes were placed in‐office for 269 patients (449 ears) and in the OR for 68 patients (131 ears) (mean age, 4.5 years). The median and mean times to tube extrusion for the combined OR and In‐Office cohorts were 15.82 (95% confidence interval [CI]: 15.41‐19.05) and 16.79 (95% CI: 16.16‐17.42) months, respectively. Sequelae included ongoing perforation for 1.9% of ears (11/580) and medial tube displacement for 0.2% (1/580) observed at 18 months. Over a mean follow‐up of 14.3 months, 30.3% (176/580) of ears had otorrhea and 14.3% (83/580) had occluded tubes.ConclusionIn‐office pediatric tympanostomy using lidocaine/epinephrine iontophoresis and automated tube delivery results in tube retention within the ranges described for similar grommet‐type tubes and complication rates consistent with traditional tube placement in the OR.
Objective: The objective would be to design a low cost, reproducible anatomic model to simulate tracheotomy in the surgical skills training laboratory. The model was adapted from a base model used previously for verification of proficiency (VOP) assessment of cricothyrotomy by general surgery residents. Method: The following materials were used: ventilator tubing, vessel loops, a 2x4x9-inch block of wood, red and white felt fabric, automotive ceiling headliner, cardboard, foam tape, adhesive spray, and foam. All materials were found easily at a local craft store or in medical discard. Results: The model was assembled by securing ventilator tubing to a block of wood to represent the trachea. Thyroid and cricoid cartilages were fashioned and secured to ensure palpable landmarks. An anterior section of ventilator tubing was removed and replaced with foam tape to allow for a recyclable base. Finally, the thyroid and superficial tissue (including vessels and strap muscles) were assembled using headliner, felt, and vessel loops. After assembly was completed, four junior residents were able to successfully palpate each landmark, “ligate” vessels, identify and retract the thyroid isthmus, and perform a tracheostomy. Conclusion: The model developed is a practical and reproducible anatomic model for simulation training of tracheotomy for otolaryngology residents and can be created utilizing inexpensive, readily available materials. In conjunction with a skills lab training session, this useful tool could play an important role in the overall evaluation of surgical competence.
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