International Journal of Pediatric Otorhinolaryngology
Autoinflation for treatment of persistent otitis media with effusion in children: A cross-over study with a 12-month follow-up
Introduction
Otitis media with effusion (OME) is an inflammation with fluid in the middle ear often combined with impaired hearing [1]. The insertion of grommets into the eardrum is one of the most common operations performed under general anaesthesia in childhood [2]. The primary indication for the operation is the restoration of normal hearing in children with long-standing bilateral OME by improving the ventilation and pressure regulation in the middle ear [1], [3], [4], [5]. However, previous studies indicate that the benefits of grommets in children with OME are limited and that the effect on hearing diminishes during the first year [4], [6], [7]. Considering the potentially adverse effects on the tympanic membrane after grommet insertion, a period of watchful waiting is recommended for most children with OME [4].
Several non-invasive methods, i.e. autoinflation, have been developed to improve the negative middle-ear pressure in children with OME [8], [9], [10], [11], [12]. Autoinflation is a technique whereby the Eustachian tube is opened by increasing the intranasal pressure [2]. This can be achieved by forced exhalation with a closed mouth and nose or by blowing up a balloon through each nostril by active inflation [2]. A Cochrane review concluded that evidence for the use of autoinflation in the short term is favourable, but, given the small number of studies and the lack of follow-up, the long-term effects cannot be determined [2].
The authors of the present study tested a new device for autoinflation, enabling a combined, modified Valsalva–Politzer manoeuvre. In a previous pilot study, 21 children, aged two to seven years, were able to perform the procedure and >80% of the children achieved improved middle-ear pressure [13]. However, due to the small number of subjects, lack of hearing evaluation and the short follow-up time, the long-term effects of this treatment could not be determined.
The aims of the present study were to: (I) evaluate the efficiency of and compliance with the new device in young children with persistent OME in a cross-over study with a follow-up period of eight weeks and (II) assess the long-term effects of the device with a follow-up period of one year.
Section snippets
Device for autoinflation
A new autoinflation device (Fig. 1) for home treatment of children with persistent OME was used in the present study. The device consisted of (1) an inflatable facemask, (2) a T-shaped junction tube connecting at one end to the facemask, another end to (3) a balloon and the third end to (4) a handheld pump. The pump was covered by (5) a teddy bear in order to improve compliance in young children.
The inflatable facemask was used to cover the nose and mouth of the child, with individual
Tympanometry
In Group A, the mean middle-ear pressure improved by 166 daPa (median 156, min 0, max 365, p < 0.0001) after four weeks of treatment in comparison with 19 daPa (median 0, min −50, max 376, p = 0.31) in Group B after four weeks of follow-up (Fig. 5).
In Group A, after four weeks of treatment, 36 ears (82%) were judged as responders, of which 19 (43%) achieved normalised (C1/A) and 17 (39%) improved (C2) middle-ear pressures, while eight ears (18%) remained unchanged and no deterioration was observed.
Discussion
The effect of autoinflation on hearing thresholds in children with OME has not been established due to the lack of studies with sufficient scientific evidence [1]. In the present study, after treatment in both groups at eight weeks, the mean hearing level improved from 22 to 16 dB and the number of ears with hearing thresholds of ≥20 dB was reduced from 61 (78%) to 17 (23%).
Previous studies report conflicting evidence in favour of the use of autoinflation in the treatment of OME in young children
Conclusions
The new device for autoinflation provides promising results in treatment of persistent OME in children. The device demonstrated efficiency in improving both middle-ear pressure and hearing thresholds in most children after four weeks of treatment in a randomised controlled cross-over study. The device was well tolerated, even in young children, with no complications reported. It might therefore be possible to consider this method of autoinflation in children with persistent OME during the
Acknowledgements
We would like to thank Radoslava Jönsson for her valuable feed-back on the article. This work was partially financed by grants from the Rune and Ulla Amlöv Foundation for Neurological, Rheumatological and Audiological Research, Sweden. The sponsor played no role whatsoever in the study design, in the collection, analysis and interpretation of data, or in the writing of the manuscript or the decision to submit the manuscript for publication.
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Clinical practice guidelines for the diagnosis and management of otitis media with effusion (OME) in children in Japan – 2022 update
2023, Auris Nasus LarynxCitation Excerpt :Therefore, the treatment should be performed frequently to increase its effectiveness. It was shown that self-treatment by opening the ET is not effective at a frequency of 1-2 times per day, but it is effective if done 3 times per day [154–156]. A systematic review found no evidence of the efficacy of tympanograms or pure-tone audiometry alone but significant benefit when they are combined.
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2019, Journal of OtologyCitation Excerpt :In particular, no double-blind trials have been performed. It has nevertheless been demonstrated that in children over the age of 2, four weeks of Politzerization was associated with improvements in middle ear pressure and in the auditory threshold (Bidarian-Moniri et al., 2014). A recent literature review of eight controlled, randomized trials (featuring a total of 702 patients) found a trend towards rapid improvement of the symptoms.
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2018, European Annals of Otorhinolaryngology, Head and Neck DiseasesCitation Excerpt :Children require motivation for long-term adherence to the treatment especially at a young age so effectiveness should not be expected in all families. One team has studied a simple system using a facemask and balloons with different opening pressures (also includes a teddy bear to increase motivation) and has found significant improvement of both middle-ear pressure and hearing after four weeks of treatment in children as young as two (Grade B) [53,54]. All panellists agreed that further studies are required to develop a standardized, cheap and easy-to-use device.
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