Long Term effectiveness of Solo+ TTD: A single step tympanostomy tube (TT) Delivery device

IF 1.3 4区医学 Q3 OTORHINOLARYNGOLOGY

International journal of pediatric otorhinolaryngology Pub Date : 2025-09-22 DOI:10.1016/j.ijporl.2025.112567

Michael E. McCormick , Diego A. Preciado , Robert H. Chun , Brian K. Reilly , Sophie G. Shay , Roxanne Link , Katherine Peterson , Hengameh K. Behzadpour , Isabel Baumgartner , Susan Anderson , Keith Jansen , Matija Daniel , Elizabeth Kane , Taylor Theriault , Emily Zetzer , Laura Davis , Joseph E. Kerschner

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引用次数: 0

Abstract

Background

Tympanostomy tube (TT) insertion is typically performed in children in the operating room under general anesthesia. Devices combining equipment and steps in TT insertion, facilitate TT placement and may enable a transition to in-office TT procedures avoiding general anesthesia. This study evaluates the safety and effectiveness of a new TT insertion device, Solo + TTD, with general anesthesia.

Methods

Children aged 6 months to 15 years meeting criteria for TT insertion were enrolled in an IRB-approved multicenter single-arm prospective study. TT insertion was performed in the operating room under general anesthesia using the study device. Intraoperative device success, rate of adverse events, function of ear tubes during follow-up (1, 3, 6, 12, 18 and 24 months), and use of additional instrumentation for placement of Solo + TT were evaluated. Interim data through 12 months of follow up are presented in this paper.

Results

A total of 59 ears in 30 patients were treated at two sites. The mean age of enrolled children was 2.4 years and 57 % were male. Solo + TT insertion was successful (± use of additional instrumentation) in 57/59 (96.6 %) ears with unsuccessful insertion in two patients due to irregular ear canal anatomy. Two ears required a second Solo + TTD cartridge for successful insertion. There were no serious adverse events related to the device or procedure. Non-serious adverse events at one-month (most common bleeding, otorrhea and blockage) occurred at rates (9/30 patients) similar to standard TT. At 1-month follow up, 96 % (51/53) ears had functioning TT. Through 12-months follow-up, 20 % of TT were extruded (9/44 ears) and 88.6 % of present TT (31/35 ears) were functioning.

Conclusion

The Solo + TTD tympanostomy tube device has a high rate of successful TT placement in children under general anesthesia. The device TTs function is similar to traditional TTs and other device TTs out to 1 year. Additional studies evaluating the device in children using topical anesthesia are needed.

查看原文本刊更多论文

Solo+ TTD的长期有效性：一种单步鼓室造瘘管（TT）输送装置。

背景：鼓膜造瘘管（TT）的插入通常在全麻下的儿童手术室进行。将TT插入的设备和步骤结合在一起的装置，方便了TT的放置，并可以过渡到办公室TT程序，避免全身麻醉。本研究评估了一种新的TT插入装置Solo + TTD在全身麻醉下的安全性和有效性。方法：年龄6个月至15岁符合TT插入标准的儿童入组irb批准的多中心单臂前瞻性研究。TT插入是在手术室全麻下使用研究装置进行的。评估术中装置的成功率、不良事件发生率、随访期间耳管的功能（1、3、6、12、18和24个月），以及使用额外的器械放置Solo + TT。本文提供了12个月随访的中期数据。结果：30例患者共59耳进行了两处治疗。入组儿童的平均年龄为2.4岁，57%为男性。57/59（96.6%）耳（±使用了额外的器械）的患者Solo + TT置入成功，2例患者由于耳道解剖不规则而置入失败。两只耳朵需要第二个Solo + TTD卡带才能成功插入。没有与器械或手术相关的严重不良事件。1个月时发生的非严重不良事件（最常见的出血、耳漏和堵塞）发生率（9/30例）与标准TT相似。在1个月的随访中，96%（51/53）的耳朵功能正常。经过12个月的随访，20%的耳塞（9/44耳），88.6%的耳塞（31/35耳）功能正常。结论：Solo + TTD鼓膜造瘘管装置在儿童全麻下TT放置成功率高。设备tt功能与传统tt和其他设备tt类似，最长为1年。需要进一步的研究来评估该装置在儿童表面麻醉中的应用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International journal of pediatric otorhinolaryngology 医学-耳鼻喉科学

CiteScore

3.20

自引率

6.70%

发文量

276

审稿时长

62 days

期刊介绍： The purpose of the International Journal of Pediatric Otorhinolaryngology is to concentrate and disseminate information concerning prevention, cure and care of otorhinolaryngological disorders in infants and children due to developmental, degenerative, infectious, neoplastic, traumatic, social, psychiatric and economic causes. The Journal provides a medium for clinical and basic contributions in all of the areas of pediatric otorhinolaryngology. This includes medical and surgical otology, bronchoesophagology, laryngology, rhinology, diseases of the head and neck, and disorders of communication, including voice, speech and language disorders.