Two‐Year Outcomes After Pediatric In‐Office Tympanostomy Using Lidocaine/Epinephrine Iontophoresis and an Automated Tube Delivery System

Objective Evaluate 2‐year outcomes after lidocaine/epinephrine iontophoresis and tympanostomy using an automated tube delivery system for pediatric tube placement in‐office. Study Design Prospective, single‐arm. Setting Eighteen otolaryngology practices. Methods Children age 6 months to 12 years ind...

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Veröffentlicht in:Otolaryngology-head and neck surgery 2023-09, Vol.169 (3), p.701-709
Hauptverfasser: Waldman, Erik H., Ingram, Amy, Vidrine, D. Macy, Gould, Andrew R., Zeiders, Jacob W., Ow, Randall A., Thompson, Christopher R., Moss, Jonathan R., Mehta, Ritvik, McClay, John E., Brenski, Amy, Gavin, John, Ansley, John, Yen, David M., Chadha, Neil K., Murray, Michael T., Kozak, Frederick K., York, Christopher, Brown, David M., Grunstein, Eli, Sprecher, Robert C., Sherman, Denise A., Schoem, Scott R., Puchalski, Robert, Hills, Susannah, Harfe, Dan, England, Laura J., Syms, Charles A., Lustig, Lawrence R.
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container_end_page 709
container_issue 3
container_start_page 701
container_title Otolaryngology-head and neck surgery
container_volume 169
creator Waldman, Erik H.
Ingram, Amy
Vidrine, D. Macy
Gould, Andrew R.
Zeiders, Jacob W.
Ow, Randall A.
Thompson, Christopher R.
Moss, Jonathan R.
Mehta, Ritvik
McClay, John E.
Brenski, Amy
Gavin, John
Ansley, John
Yen, David M.
Chadha, Neil K.
Murray, Michael T.
Kozak, Frederick K.
York, Christopher
Brown, David M.
Grunstein, Eli
Sprecher, Robert C.
Sherman, Denise A.
Schoem, Scott R.
Puchalski, Robert
Hills, Susannah
Harfe, Dan
England, Laura J.
Syms, Charles A.
Lustig, Lawrence R.
description Objective Evaluate 2‐year outcomes after lidocaine/epinephrine iontophoresis and tympanostomy using an automated tube delivery system for pediatric tube placement in‐office. Study Design Prospective, single‐arm. Setting Eighteen otolaryngology practices. Methods Children 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. Results Tubes 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. Conclusion In‐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.
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Macy ; Gould, Andrew R. ; Zeiders, Jacob W. ; Ow, Randall A. ; Thompson, Christopher R. ; Moss, Jonathan R. ; Mehta, Ritvik ; McClay, John E. ; Brenski, Amy ; Gavin, John ; Ansley, John ; Yen, David M. ; Chadha, Neil K. ; Murray, Michael T. ; Kozak, Frederick K. ; York, Christopher ; Brown, David M. ; Grunstein, Eli ; Sprecher, Robert C. ; Sherman, Denise A. ; Schoem, Scott R. ; Puchalski, Robert ; Hills, Susannah ; Harfe, Dan ; England, Laura J. ; Syms, Charles A. ; Lustig, Lawrence R.</creator><creatorcontrib>Waldman, Erik H. ; Ingram, Amy ; Vidrine, D. Macy ; Gould, Andrew R. ; Zeiders, Jacob W. ; Ow, Randall A. ; Thompson, Christopher R. ; Moss, Jonathan R. ; Mehta, Ritvik ; McClay, John E. ; Brenski, Amy ; Gavin, John ; Ansley, John ; Yen, David M. ; Chadha, Neil K. ; Murray, Michael T. ; Kozak, Frederick K. ; York, Christopher ; Brown, David M. ; Grunstein, Eli ; Sprecher, Robert C. ; Sherman, Denise A. ; Schoem, Scott R. ; Puchalski, Robert ; Hills, Susannah ; Harfe, Dan ; England, Laura J. ; Syms, Charles A. ; Lustig, Lawrence R.</creatorcontrib><description>Objective Evaluate 2‐year outcomes after lidocaine/epinephrine iontophoresis and tympanostomy using an automated tube delivery system for pediatric tube placement in‐office. Study Design Prospective, single‐arm. Setting Eighteen otolaryngology practices. Methods Children 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. Results Tubes 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. Conclusion In‐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.</description><identifier>ISSN: 0194-5998</identifier><identifier>EISSN: 1097-6817</identifier><identifier>DOI: 10.1002/ohn.336</identifier><identifier>PMID: 37003297</identifier><language>eng</language><publisher>England</publisher><subject>automated tube insertion ; iontophoresis ; local anesthesia ; office tympanostomy ; pediatric ; Tula ; tympanostomy tube</subject><ispartof>Otolaryngology-head and neck surgery, 2023-09, Vol.169 (3), p.701-709</ispartof><rights>2023 The Authors. Otolaryngology–Head and Neck Surgery published by Wiley Periodicals LLC on behalf of American Academy of Otolaryngology–Head and Neck Surgery Foundation.</rights><rights>2023 The Authors. Otolaryngology-Head and Neck Surgery published by Wiley Periodicals LLC on behalf of American Academy of Otolaryngology-Head and Neck Surgery Foundation.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3506-e014a4476a540f53aad56a2067ab4c13378b231fb2dad8669a0263de227c6acb3</citedby><cites>FETCH-LOGICAL-c3506-e014a4476a540f53aad56a2067ab4c13378b231fb2dad8669a0263de227c6acb3</cites><orcidid>0000-0003-1368-7019</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fohn.336$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fohn.336$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37003297$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Waldman, Erik H.</creatorcontrib><creatorcontrib>Ingram, Amy</creatorcontrib><creatorcontrib>Vidrine, D. Macy</creatorcontrib><creatorcontrib>Gould, Andrew R.</creatorcontrib><creatorcontrib>Zeiders, Jacob W.</creatorcontrib><creatorcontrib>Ow, Randall A.</creatorcontrib><creatorcontrib>Thompson, Christopher R.</creatorcontrib><creatorcontrib>Moss, Jonathan R.</creatorcontrib><creatorcontrib>Mehta, Ritvik</creatorcontrib><creatorcontrib>McClay, John E.</creatorcontrib><creatorcontrib>Brenski, Amy</creatorcontrib><creatorcontrib>Gavin, John</creatorcontrib><creatorcontrib>Ansley, John</creatorcontrib><creatorcontrib>Yen, David M.</creatorcontrib><creatorcontrib>Chadha, Neil K.</creatorcontrib><creatorcontrib>Murray, Michael T.</creatorcontrib><creatorcontrib>Kozak, Frederick K.</creatorcontrib><creatorcontrib>York, Christopher</creatorcontrib><creatorcontrib>Brown, David M.</creatorcontrib><creatorcontrib>Grunstein, Eli</creatorcontrib><creatorcontrib>Sprecher, Robert C.</creatorcontrib><creatorcontrib>Sherman, Denise A.</creatorcontrib><creatorcontrib>Schoem, Scott R.</creatorcontrib><creatorcontrib>Puchalski, Robert</creatorcontrib><creatorcontrib>Hills, Susannah</creatorcontrib><creatorcontrib>Harfe, Dan</creatorcontrib><creatorcontrib>England, Laura J.</creatorcontrib><creatorcontrib>Syms, Charles A.</creatorcontrib><creatorcontrib>Lustig, Lawrence R.</creatorcontrib><title>Two‐Year Outcomes After Pediatric In‐Office Tympanostomy Using Lidocaine/Epinephrine Iontophoresis and an Automated Tube Delivery System</title><title>Otolaryngology-head and neck surgery</title><addtitle>Otolaryngol Head Neck Surg</addtitle><description>Objective Evaluate 2‐year outcomes after lidocaine/epinephrine iontophoresis and tympanostomy using an automated tube delivery system for pediatric tube placement in‐office. Study Design Prospective, single‐arm. Setting Eighteen otolaryngology practices. Methods Children 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. Results Tubes 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. Conclusion In‐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.</description><subject>automated tube insertion</subject><subject>iontophoresis</subject><subject>local anesthesia</subject><subject>office tympanostomy</subject><subject>pediatric</subject><subject>Tula</subject><subject>tympanostomy tube</subject><issn>0194-5998</issn><issn>1097-6817</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><recordid>eNp1kM1u1DAURi0EokNBvAHyDiSU1j-JnSxHbaEjjRgkpgtW0Y19wxglcbATqux4gC76jDwJrqawY-HPm3PP4hDymrMzzpg494fhTEr1hKw4q3SmSq6fkhXjVZ4VVVWekBcxfmeMKaX1c3IiNWNSVHpF7va3_vev-68Ige7myfgeI123Ewb6Ga2DKThDN0NCdm3rDNL90o8w-Dj5fqE30Q3f6NZZb8ANeH41ph0PIS3d-GHy48EHjC5SGGx6dD2nO5jQ0v3cIL3Ezv3EsNAvS5ywf0metdBFfPX4n5KbD1f7i-tsu_u4uVhvMyMLpjJkPIc81wqKnLWFBLCFAsGUhiY3XEpdNkLythEWbKlUBUwoaVEIbRSYRp6Sd0fvGPyPGeNU9y4a7DoY0M-xFrqSVZmmSOjbI2qCjzFgW4_B9RCWmrP6IX2d0tcpfSLfPErnpkf7j_vbOgHvj8Ct63D5n6feXX960P0B3fKQqQ</recordid><startdate>202309</startdate><enddate>202309</enddate><creator>Waldman, Erik H.</creator><creator>Ingram, Amy</creator><creator>Vidrine, D. Macy</creator><creator>Gould, Andrew R.</creator><creator>Zeiders, Jacob W.</creator><creator>Ow, Randall A.</creator><creator>Thompson, Christopher R.</creator><creator>Moss, Jonathan R.</creator><creator>Mehta, Ritvik</creator><creator>McClay, John E.</creator><creator>Brenski, Amy</creator><creator>Gavin, John</creator><creator>Ansley, John</creator><creator>Yen, David M.</creator><creator>Chadha, Neil K.</creator><creator>Murray, Michael T.</creator><creator>Kozak, Frederick K.</creator><creator>York, Christopher</creator><creator>Brown, David M.</creator><creator>Grunstein, Eli</creator><creator>Sprecher, Robert C.</creator><creator>Sherman, Denise A.</creator><creator>Schoem, Scott R.</creator><creator>Puchalski, Robert</creator><creator>Hills, Susannah</creator><creator>Harfe, Dan</creator><creator>England, Laura J.</creator><creator>Syms, Charles A.</creator><creator>Lustig, Lawrence R.</creator><scope>24P</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-1368-7019</orcidid></search><sort><creationdate>202309</creationdate><title>Two‐Year Outcomes After Pediatric In‐Office Tympanostomy Using Lidocaine/Epinephrine Iontophoresis and an Automated Tube Delivery System</title><author>Waldman, Erik H. ; Ingram, Amy ; Vidrine, D. Macy ; Gould, Andrew R. ; Zeiders, Jacob W. ; Ow, Randall A. ; Thompson, Christopher R. ; Moss, Jonathan R. ; Mehta, Ritvik ; McClay, John E. ; Brenski, Amy ; Gavin, John ; Ansley, John ; Yen, David M. ; Chadha, Neil K. ; Murray, Michael T. ; Kozak, Frederick K. ; York, Christopher ; Brown, David M. ; Grunstein, Eli ; Sprecher, Robert C. ; Sherman, Denise A. ; Schoem, Scott R. ; Puchalski, Robert ; Hills, Susannah ; Harfe, Dan ; England, Laura J. ; Syms, Charles A. ; Lustig, Lawrence R.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3506-e014a4476a540f53aad56a2067ab4c13378b231fb2dad8669a0263de227c6acb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>automated tube insertion</topic><topic>iontophoresis</topic><topic>local anesthesia</topic><topic>office tympanostomy</topic><topic>pediatric</topic><topic>Tula</topic><topic>tympanostomy tube</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Waldman, Erik H.</creatorcontrib><creatorcontrib>Ingram, Amy</creatorcontrib><creatorcontrib>Vidrine, D. 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Macy</au><au>Gould, Andrew R.</au><au>Zeiders, Jacob W.</au><au>Ow, Randall A.</au><au>Thompson, Christopher R.</au><au>Moss, Jonathan R.</au><au>Mehta, Ritvik</au><au>McClay, John E.</au><au>Brenski, Amy</au><au>Gavin, John</au><au>Ansley, John</au><au>Yen, David M.</au><au>Chadha, Neil K.</au><au>Murray, Michael T.</au><au>Kozak, Frederick K.</au><au>York, Christopher</au><au>Brown, David M.</au><au>Grunstein, Eli</au><au>Sprecher, Robert C.</au><au>Sherman, Denise A.</au><au>Schoem, Scott R.</au><au>Puchalski, Robert</au><au>Hills, Susannah</au><au>Harfe, Dan</au><au>England, Laura J.</au><au>Syms, Charles A.</au><au>Lustig, Lawrence R.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Two‐Year Outcomes After Pediatric In‐Office Tympanostomy Using Lidocaine/Epinephrine Iontophoresis and an Automated Tube Delivery System</atitle><jtitle>Otolaryngology-head and neck surgery</jtitle><addtitle>Otolaryngol Head Neck Surg</addtitle><date>2023-09</date><risdate>2023</risdate><volume>169</volume><issue>3</issue><spage>701</spage><epage>709</epage><pages>701-709</pages><issn>0194-5998</issn><eissn>1097-6817</eissn><abstract>Objective Evaluate 2‐year outcomes after lidocaine/epinephrine iontophoresis and tympanostomy using an automated tube delivery system for pediatric tube placement in‐office. Study Design Prospective, single‐arm. Setting Eighteen otolaryngology practices. Methods Children 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. Results Tubes 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. Conclusion In‐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.</abstract><cop>England</cop><pmid>37003297</pmid><doi>10.1002/ohn.336</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0003-1368-7019</orcidid><oa>free_for_read</oa></addata></record>
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source Wiley Online Library Journals
subjects automated tube insertion
iontophoresis
local anesthesia
office tympanostomy
pediatric
Tula
tympanostomy tube
title Two‐Year Outcomes After Pediatric In‐Office Tympanostomy Using Lidocaine/Epinephrine Iontophoresis and an Automated Tube Delivery System
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