Autoinflation After Tympanostomy Tube Extrusion in Otitis Media With Effusion: A Randomized Clinical Trial.

Abstract

Otitis media with effusion (OME) is a common condition in children that can lead to hearing loss and developmental delays. Although tympanostomy tube (TT) placement is the standard treatment for persistent OME, recurrence after tube extrusion and the need for reoperation remain significant concerns. To evaluate the clinical effectiveness of autoinflation in reducing OME recurrence and reoperation rates after TT extrusion in pediatric patients. This prospective randomized clinical trial, conducted from September 2019 to August 2022 at a tertiary hospital, enrolled children with chronic OME who underwent TT placement with 2 years of follow-up after TT extrusion. The statistical analysis took place between March 2024 and February 2025. After TT extrusion, patients were randomized to receive autoinflation with the autoinflation device for 5 weeks or to undergo observation alone. The main outcomes were OME recurrence and reoperation rates using otoscopic and tympanometric evaluations. Sixty-six children enrolled in the study; 54 were included in the final analysis (26 in the autoinflation group and 28 in the observation group). Among 54 children (mean [SD] age, 55.5 [18.5] months; 30 [55.6%] male), the recurrence rate was 5 of 26 patients (19.2%) in the autoinflation group and much higher at 10 of 28 patients (35.7%) in the observation group (difference, 16.5 percentage points [pp]; 95% CI, -7.4 pp to 37.8 pp), while the reoperation rate was much lower in the autoinflation group at 2 of 26 patients (7.7%) compared to the observation group at 8 of 28 patients (28.6%; difference, 20.9 pp; 95% CI,-0.29 pp to 40.2 pp). In the autoinflation group, tympanometry showed minimal change from the first follow-up after TT extrusion to after 5 weeks of autoinflation therapy (type A tympanogram: 19 of 26 patients [73.1%] to 20 of 26 patients [76.9%]; type C tympanogram: 7 of 26 patients [26.9%] to 6 of 26 patients [23.1%]). In contrast, the observation group exhibited a decline in type A tympanograms (21 of 28 patients [75.0%] to 16 of 28 patients [57.1%]) and an increase in type C tympanograms (7 of 28 patients [25.0%] to 12 of 28 patients [42.9%]). In this randomized clinical trial, autoinflation after TT extrusion was safe, feasible, and associated with a reduced need for repeat surgical intervention. The observed difference in recurrence was compatible with a clinically meaningful reduction. These findings support the use of autoinflation as a noninvasive rehabilitative strategy to enhance eustachian tube function and maintain middle ear ventilation following TT extrusion. ClinicalTrials.gov Identifier: NCT07122999.