Dataset Information

In-Office Tympanostomy Tube Placement Using Iontophoresis and Automated Tube Delivery Systems.

ABSTRACT: 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.

SUBMITTER: Yen DM

PROVIDER: S-EPMC7040928 | biostudies-literature | 2020 Jan-Mar

REPOSITORIES: biostudies-literature

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In-Office Tympanostomy Tube Placement Using Iontophoresis and Automated Tube Delivery Systems.

Yen David M DM Murray Michael T MT Puchalski Robert R Gould Andrew R AR Ansley John J Ow Randall A RA Moss Jonathan R JR England Laura J LJ Syms Charles A CA

OTO open 20200101 1

<h4>Objectives</h4>(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.<h4>Study design</h4>Prospective, multicenter, single arm.<h4>Setting</h4>Patients were recruited in 8 community-based practices in the United States between June and September 2017.<h4>Subjects and methods</h4>This study evaluated tympanic membr ...[more]

PMID: 32133434

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Project description:BackgroundBecause previous studies have indicated that otitis media may be a polymicrobial disease, we prospectively analyzed middle ear effusions of children undergoing tympanostomy tube placement with multiplex polymerase chain reaction for four otopathogens.MethodsMiddle ear effusions from 207 children undergoing routine tympanostomy tube placement were collected and were classified by the surgeon as acute otitis media (AOM) for purulent effusions and as otitis media with effusion (OME) for non-purulent effusions. DNA was isolated from these samples and analyzed with multiplex polymerase chain reaction for Haemophilus influenzae, Streptococcus pneumoniae, Alloiococcus otitidis, and Moraxella catarrhalis.Results119 (57%) of 207 patients were PCR positive for at least one of these four organisms. 36 (30%) of the positive samples indicated the presence of more than one bacterial species. Patient samples were further separated into 2 groups based on clinical presentation at the time of surgery. Samples were categorized as acute otitis media (AOM) if pus was observed behind the tympanic membrane. If no pus was present, samples were categorized as otitis media with effusion (OME). Bacteria were identified in most of the children with AOM (87%) and half the children with OME (51%, p < 0.001). A single bacterial organism was detected in middle ear effusions from children with AOM more often than those with OME (74% versus 33%, p < 0.001). Haemophilus influenzae was the predominant single organism and caused 58% of all AOM in this study. Alloiococcus otitidis and Moraxella catarrhalis were more frequently identified in middle ear effusions than Streptococcus pneumoniae.ConclusionsHaemophilus influenzae, Streptococcus pneumoniae, Alloiococcus otitidis, and Moraxella catarrhalis were identified in the middle ear effusions of some patients with otitis media. Overall, we found AOM is predominantly a single organism infection and most commonly from Haemophilus influenzae. In contrast, OME infections had a more equal distribution of single organisms, polymicrobial entities, and non-bacterial agents.

Dataset Information

In-Office Tympanostomy Tube Placement Using Iontophoresis and Automated Tube Delivery Systems.

Publications

In-Office Tympanostomy Tube Placement Using Iontophoresis and Automated Tube Delivery Systems.

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