In-office insertion tympanostomy tubes in children using single-pass device

Theodore O Truitt, James R Kosko, Grace L Nimmons, Jay Raisen, Sandra M Skovlund, Frank Rimell, Shelagh A Cofer, Theodore O Truitt, James R Kosko, Grace L Nimmons, Jay Raisen, Sandra M Skovlund, Frank Rimell, Shelagh A Cofer

Abstract

Objectives: Insertion of tympanostomy tubes (TT) is generally accomplished in children in the operating room under general anesthesia. We report on 229 children treated in-office with a novel device.

Methods: Investigators participated in an IRB-approved, prospective, single arm, multisite investigation of in-office TT placement in awake children. Topical anesthetic was applied, and protective restraint was used. TT placement was performed with a single-pass TT insertion device. Safety was assessed by monitoring procedural events.

Results: Four hundred and forty-four ears were treated in 229 children at 10 sites. Children were in age groups 6-24 months (n = 211, mean = 13 months) and 5-12 years (n = 18, mean = 8.3 years). Two hundred and fifteen children received bilateral TT placement, and 14 received unilateral placement. Overall, 226/229 (98.7%) children had successful TT placement in the office (209/211 in 6-24 months and 17/18 in 5-12 years). Three children were rescheduled for the operating room due to anatomical challenges or patient movement. Median procedure time for bilateral cases in both age groups was 4:53. Two minor adverse events (AEs) were reported in one patient. Per independent assessment of 30 procedure videos by clinicians, TT placement was tolerated acceptably by all children.

Conclusion: In-office TT placement in awake young children using topical anesthetic, enabled by a single pass delivery device, was safe, successful and well tolerated. The American Academy of Otolaryngology (AAO) recently released a Position Statement supporting in-office TT placement in appropriate children. These results affirm an in-office alternative for clinicians and parents who have concerns with the risk, inconvenience and cost of surgery in an operating room under general anesthesia.Level of Evidence: 2c.Clinical Trials Registration Number: NCT03544138.

Keywords: children; office; otitis media; tympanostomy tubes.

Conflict of interest statement

Theodore O. Truitt—Preceptis Medical (Consultant); Stryker ENT (Consultant). James R. Kosko—None. Grace L. Nimmons—None. Jay Raisen—Intersect ENT (Consulting Services). Sandra M. Skovlund—Skovlund Medical Products (Founder); Inspire Medical (Consultant). Frank Rimell—Preceptis Medical (Consultant and Medical Director). Shelagh A. Cofer—None.

© 2021 The Authors. Laryngoscope Investigative Otolaryngology published by Wiley Periodicals LLC. on behalf of The Triological Society.

Figures

FIGURE 1
FIGURE 1
Tympanostomy tube used with the Hummingbird Tympanostomy Tube System
FIGURE 2
FIGURE 2
Results from parent satisfaction survey

References

    1. Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, 2006. Natl Heal Stat Rep. 2009;11:1‐25.
    1. Hoffman KK, Thomson KG, Burke BL, Derkay CS. Anesthetic complications of tympanostomy tube placement in children. Arch Otolaryngol Head Neck Surg. 2002;128:1040‐1043.
    1. Miller RD, Pardo M. Basics of Anesthesia. 6th ed. Philadelphia, PA: Elsevier; 2011.
    1. Cravero JP, Beach M, Dodge CP, Whalen K. Emergence characteristics of sevoflurane compared to halothane in pediatric patients undergoing bilateral pressure equalization tube insertion. J Clin Anesth. 2000;12(5):397‐401.
    1. FDA Drug Safety Communication: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women. Published December 14, 2016.
    1. Rosenfeld RM, Sury K, Macarinas C. Office insertion of tympanostomy tubes without anesthesia in young children. Otolaryngol Head Neck Surg. 2015;153(6):1067‐1070.
    1. Cofer S, Meyer A, Yoon D, et al. Tympanostomy tube placement in children using a single‐pass tool with moderate sedation. Otolaryngol Head Neck Surg. 2017;157(3):533‐535.
    1. Rosenfeld RM, Shin JJ, Schwartz SR, et al. Clinical practice guideline: otitis media with effusion (update). Otolaryngol Head Neck Surg. 2016;154(1 suppl):S1‐S41.
    1. Lieberthal AS, Carroll AE, Chonmaitree T, et al. The diagnosis and management of acute otitis media. Pediatrics. 2013;131(3):e964‐e999.
    1. Warner D, Zaccariello MJ, Katusic SK, et al. Neuropsychological and behavioral outcomes after exposure of young children to procedures requiring general anesthesia: the Mayo Anesthesia Safety in Kids (MASK) study. Anesthesiology. 2018;129(1):89‐105.
    1. Boston MK, McCook J, Burke B, Derkay C. Incidence of and risk factors for additional Tympanostomy tube insertion in children. Arch Otolaryngol Head Neck Surg. 2003;129(3):293‐296.
    1. O'Neil MB, Cassidy LD, Link TR, Kerschner JE. Tracking tympanostomy tube outcomes in pediatric patients with otitis media using an electronic database. Int J Pediatr Otorhinolaryngol. 2015;79(8):1275‐1278.
    1. Rosenfeld RM. Shared decision making and office insertion of tympanostomy tubes. Otolaryngol Head Neck Surg. 2016;154(5):807‐809.
    1. UptoDate. Wolters Kluwer; 2019.
    1. Zeiders JW, Syms CA, Mitskavich MT, et al. Tympanostomy tube placement in awake, unrestrained pediatric patients: a prospective, multicenter study. Int J Pediatr Otorhinolaryngol. 2015;79(12):2416‐2423.
    1. Brodsky L, Brookhauser P, Chait D, et al. Office‐based insertion of pressure equalization: tubes the role of laser assisted tympanic membrane fenestration. Laryngoscope. 1999;109(12):2009‐2014.
    1. Summerfield MJ, White PS. Ventilation tube insertion using topical anesthesia in children. J Laryngol Otol. 1992;106(5):427‐428.
    1. Friedman O, Deutsch ES, Reilly JS, Cook SP. The feasibility of office‐based laser‐assisted tympanic membrane fenestration with tympanostomy tube insertion: the DuPont Hospital experience. Int J Pediatr Otorhinolaryngol. 2002;62(1):31‐35.
    1. Lustig LR, Ingram A, Vidrine DM, et al. In‐office tympanostomy tube placement in children using Iontophoresis and automated tube delivery. Laryngoscope. 2020;130(suppl 4):S1‐S9.
    1. Cohen B, Thevenin A, Mille‐Zemmoura B, Moenne‐Loccoz J, Remerand F, Laffon M. Anxiety during inhalation induction in paediatrics: sitting versus supine position, a randomized trial. Anaesth Crit Care Pain Med. 2018;37(5):435‐438.
    1. Fortier MA, Del Rosario AM, Martin SR, Kain ZN. Perioperative anxiety in children. Paediatr Anaesth. 2010;20(4):318‐322.
    1. Fortier MA, Kain ZN. Treating perioperative anxiety and pain in children: a tailored and innovative approach. Paediatr Anaesth. 2015;25(1):27‐35.
    1. AAO‐HNS Position Statement. In‐Office Placement of Tubes in Pediatric Patients While Awake. . Accessed September 24, 2020.
    1. Davidson J, Ioanidis K, Fantillo V, Paradis J, Strychowsky J. Cost and efficiency of myringotomy procedures in minor procedure rooms compared to operating rooms. Laryngoscope. 2020;130(1):242‐246.

Source: PubMed

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