Truitt Theodore O, Kosko James R, Nimmons Grace L, Raisen Jay, Skovlund Sandra M, Rimell Frank, Cofer Shelagh A
St. Cloud ENT St. Cloud Minnesota USA.
Children's Ear, Nose, Throat & Allergy (CENTA) Orlando Florida USA.
Laryngoscope Investig Otolaryngol. 2021 Feb 2;6(2):325-331. doi: 10.1002/lio2.533. eCollection 2021 Apr.
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.
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.
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.
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.
鼓膜置管术（TT）通常在手术室对儿童实施全身麻醉的情况下进行。我们报告了229名使用一种新型装置在门诊接受治疗的儿童情况。
研究人员参与了一项经机构审查委员会批准的、前瞻性、单臂、多中心的关于在清醒儿童中进行门诊鼓膜置管术的调查。使用了局部麻醉剂，并采用了保护性约束措施。使用单次通过的鼓膜置管装置进行鼓膜置管。通过监测手术过程中的事件来评估安全性。
在10个地点的229名儿童中，共治疗了444只耳朵。儿童年龄组为6至24个月（n = 211，平均 = 13个月）和5至12岁（n = 18，平均 = 8.3岁）。215名儿童接受了双侧鼓膜置管，14名接受了单侧置管。总体而言，229名儿童中有226名（98.7%）在门诊成功进行了鼓膜置管（6至24个月组中的209/211名和5至12岁组中的17/18名）。3名儿童因解剖结构问题或患者移动而被重新安排到手术室。两个年龄组双侧病例的中位手术时间为4:53。一名患者报告了两起轻微不良事件（AE）。根据临床医生对30个手术视频的独立评估，所有儿童对鼓膜置管的耐受性均可接受。
使用局部麻醉剂在清醒幼儿中进行门诊鼓膜置管术，通过单次通过的输送装置得以实现，是安全、成功且耐受性良好的。美国耳鼻咽喉头颈外科学会（AAO）最近发布了一份立场声明，支持在合适的儿童中进行门诊鼓膜置管术。这些结果为那些对全身麻醉下手术室手术的风险、不便和成本存在担忧的临床医生和家长提供了一种门诊替代方案。证据水平：2c。临床试验注册号：NCT03544138。
