In-Office Tympanostomy Tube Placement Using Iontophoresis and Automated Tube Delivery Systems
Objectives (1) To evaluate safety, tolerability, and technical success of lidocaine iontophoresis and a tympanostomy tube placement system for adults in an office setting and (2) to meet regulatory evidence requirements for new drugs and devices. Study Design Prospective, multicenter, single arm. Se...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2020-02-01
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| Series: | OTO Open |
| Online Access: | https://doi.org/10.1177/2473974X20903125 |
| _version_ | 1827615166786699264 |
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| author | David M. Yen MD Michael T. Murray MD Robert Puchalski MD Andrew R. Gould MD John Ansley MD Randall A. Ow MD Jonathan R. Moss MD Laura J. England PhD Charles A. Syms MD |
| author_facet | David M. Yen MD Michael T. Murray MD Robert Puchalski MD Andrew R. Gould MD John Ansley MD Randall A. Ow MD Jonathan R. Moss MD Laura J. England PhD Charles A. Syms MD |
| author_sort | David M. Yen MD |
| collection | DOAJ |
| description | Objectives (1) To evaluate safety, tolerability, and technical success of lidocaine iontophoresis and a tympanostomy tube placement system for adults in an office setting and (2) to meet regulatory evidence requirements for new drugs and devices. Study Design Prospective, multicenter, single arm. Setting Patients were recruited in 8 community-based practices in the United States between June and September 2017. Subjects and Methods This study evaluated tympanic membrane anesthesia and tube placement in 30 adults. Anesthesia was achieved via iontophoresis of a lidocaine/epinephrine solution. Tube placement was conducted using an integrated myringotomy and tube delivery system. Tolerability of tube placement was measured using a patient-reported visual analog scale from 0 mm ( no pain ) to 100 mm ( worst possible pain ). Mean pain score was compared to a performance goal of 45 mm, where statistical superiority represents mild pain or less. Technical success and safety through 3 weeks postprocedure were evaluated. Results Twenty-nine (29/30, 96.7%) patients had tube(s) successfully placed in all indicated ears. One patient demonstrated inadequate tympanic membrane anesthesia, and no tube placement was attempted. The mean (SD) pain score of 9.4 (15.7) mm was statistically superior to the performance goal. There were no serious adverse events. Seven nonserious events were related to device, procedure, or drug: inadequate anesthesia (1), vertigo (1), and dizziness (1) at the time of procedure and ear discomfort (1), tube occlusion (2), and medial tube migration (1) postprocedure. Conclusion Lidocaine iontophoresis provides acceptable tympanic membrane anesthesia for safe, tolerable, and successful in-office tube placement using an integrated myringotomy and tube delivery system. |
| first_indexed | 2024-03-09T09:07:16Z |
| format | Article |
| id | doaj.art-96a08b6510224189a10a32c15b10d6ba |
| institution | Directory Open Access Journal |
| issn | 2473-974X |
| language | English |
| last_indexed | 2024-03-09T09:07:16Z |
| publishDate | 2020-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | OTO Open |
| spelling | doaj.art-96a08b6510224189a10a32c15b10d6ba2023-12-02T10:10:13ZengWileyOTO Open2473-974X2020-02-01410.1177/2473974X20903125In-Office Tympanostomy Tube Placement Using Iontophoresis and Automated Tube Delivery SystemsDavid M. Yen MD0Michael T. Murray MD1Robert Puchalski MD2Andrew R. Gould MD3John Ansley MD4Randall A. Ow MD5Jonathan R. Moss MD6Laura J. England PhD7Charles A. Syms MD8Specialty Physician Associates, Bethlehem, Pennsylvania, USACamino Ear, Nose & Throat Clinic, San Jose, California, USASouth Carolina ENT Allergy & Sleep Medicine, Columbia, South Carolina, USAAdvanced ENT & Allergy, Louisville, Kentucky, USACarolina Ear Nose & Throat Clinic, Orangeburg, South Carolina, USASacramento Ear, Nose and Throat, Roseville, California, USACharlotte Eye Ear Nose & Throat Associates, Matthews, North Carolina, USATusker Medical, Menlo Park, California, USAEar Medical Group, San Antonio, Texas, USAObjectives (1) To evaluate safety, tolerability, and technical success of lidocaine iontophoresis and a tympanostomy tube placement system for adults in an office setting and (2) to meet regulatory evidence requirements for new drugs and devices. Study Design Prospective, multicenter, single arm. Setting Patients were recruited in 8 community-based practices in the United States between June and September 2017. Subjects and Methods This study evaluated tympanic membrane anesthesia and tube placement in 30 adults. Anesthesia was achieved via iontophoresis of a lidocaine/epinephrine solution. Tube placement was conducted using an integrated myringotomy and tube delivery system. Tolerability of tube placement was measured using a patient-reported visual analog scale from 0 mm ( no pain ) to 100 mm ( worst possible pain ). Mean pain score was compared to a performance goal of 45 mm, where statistical superiority represents mild pain or less. Technical success and safety through 3 weeks postprocedure were evaluated. Results Twenty-nine (29/30, 96.7%) patients had tube(s) successfully placed in all indicated ears. One patient demonstrated inadequate tympanic membrane anesthesia, and no tube placement was attempted. The mean (SD) pain score of 9.4 (15.7) mm was statistically superior to the performance goal. There were no serious adverse events. Seven nonserious events were related to device, procedure, or drug: inadequate anesthesia (1), vertigo (1), and dizziness (1) at the time of procedure and ear discomfort (1), tube occlusion (2), and medial tube migration (1) postprocedure. Conclusion Lidocaine iontophoresis provides acceptable tympanic membrane anesthesia for safe, tolerable, and successful in-office tube placement using an integrated myringotomy and tube delivery system.https://doi.org/10.1177/2473974X20903125 |
| spellingShingle | David M. Yen MD Michael T. Murray MD Robert Puchalski MD Andrew R. Gould MD John Ansley MD Randall A. Ow MD Jonathan R. Moss MD Laura J. England PhD Charles A. Syms MD In-Office Tympanostomy Tube Placement Using Iontophoresis and Automated Tube Delivery Systems OTO Open |
| title | In-Office Tympanostomy Tube Placement Using Iontophoresis and Automated Tube Delivery Systems |
| title_full | In-Office Tympanostomy Tube Placement Using Iontophoresis and Automated Tube Delivery Systems |
| title_fullStr | In-Office Tympanostomy Tube Placement Using Iontophoresis and Automated Tube Delivery Systems |
| title_full_unstemmed | In-Office Tympanostomy Tube Placement Using Iontophoresis and Automated Tube Delivery Systems |
| title_short | In-Office Tympanostomy Tube Placement Using Iontophoresis and Automated Tube Delivery Systems |
| title_sort | in office tympanostomy tube placement using iontophoresis and automated tube delivery systems |
| url | https://doi.org/10.1177/2473974X20903125 |
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