Pediatric patients who used autoinflation therapy following tympanostomy tube extrusion had numerically lower rates of recurrent otitis media with effusion and repeat tube placement compared with patients assigned to observation alone, according to a randomized clinical trial.
The prospective randomized clinical trial was conducted at Pusan National University Hospital in Busan, Republic of Korea, from September 2019 to August 2022. Researchers enrolled pediatric patients aged 3 to 8 years with chronic otitis media with effusion in at least 1 ear who underwent tympanostomy tube placement for disease persisting longer than 3 months and were considered capable of performing autoinflation.
Following tube extrusion, patients were assigned to receive 5 weeks of autoinflation with Eustachi, an automated handheld Politzer device from Summit Medical, or observation alone. The autoinflation regimen consisted of twice-daily use, with 2 applications per nostril at each session, performed with caregiver assistance. Patients and caregivers were instructed not to use the device during an upper respiratory tract infection.
Of 108 patients assessed for eligibility, 66 were enrolled and randomized following tube extrusion. The final analysis included 54 patients: 26 in the autoinflation group and 28 in the observation group. Four patients in the autoinflation group and 5 in the observation group were lost to follow-up, and 3 patients assigned to autoinflation were excluded because they were unable to use the device successfully following training.
The main outcomes were recurrence of otitis media with effusion and reoperation rates, assessed with otoscopic and tympanometric evaluations over 2 years following tube extrusion.
Recurrent otitis media with effusion occurred in 19% of patients in the autoinflation group compared with 36% of patients in the observation group. Repeat tympanostomy tube placement was required in 8% vs 29% of patients, respectively.
After adjustment for age at tube placement, time to tube extrusion, and preoperative tympanogram findings, autoinflation remained associated with lower odds of reoperation, although the researchers noted that the analysis was based on a small number of events. For recurrence, the adjusted estimate numerically favored autoinflation, but the confidence interval was wide and included no difference, limiting certainty about that finding.
Tympanometry findings suggested more stable middle ear pressure among patients assigned to autoinflation. In the autoinflation group, the proportion of patients with type A tympanograms increased from 73% at the first visit following tube extrusion to 77% after 5 weeks of therapy, while type C tympanograms decreased from 27% to 23%. In the observation group, type A tympanograms decreased from 75% to 57%, while type C tympanograms increased from 25% to 43%.
No serious adverse events related to autoinflation or observation were reported during the study period.
The researchers cautioned that the trial’s small sample size and low number of recurrence and reoperation events limited the precision of the findings. Treatment adherence was monitored through caregiver instruction and follow-up visits but was not quantitatively measured. The single-center design and exclusion of patients who could not perform autoinflation may also limit generalizability.
Disclosures: The study was supported by the Bio and Medical Technology Development Program of the National Research Foundation funded by the Korean government. The funder had no role in the design or conduct of the study; collection, management, analysis, or interpretation of the data; manuscript preparation, review, or approval; or the decision to submit the manuscript for publication. The researchers reported no conflicts of interest.
