Autoinflation for treatment of persistent otitis media with effusion in children: A cross-over study with a 12-month follow-up

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Abstract

Objectives

The aims of the present study were to evaluate the efficacy of and compliance with a new device for autoinflation in the treatment of persistent otitis media with effusion (OME) in young children.

Methods

Forty-five children with persistent OME with a bilateral type B or C2 tympanogram for at least three months and history of subjective hearing loss, waiting for grommet surgery, were randomised to a treatment and a control group. Twenty-three children aged between three and eight years started as the treatment group with the new device for autoinflation. Another 22 children, aged between two and eight years were included as controls. After a period of four weeks, a cross-over was performed. Both groups underwent otomicroscopy, tympanometry and audiometry at inclusion and after one and two months for the evaluation of treatment efficiency. The primary outcome measurements were improvement in middle-ear pressure and hearing thresholds at eight weeks. Both groups were then followed up for another 10 months.

Results

In the treatment group, the mean middle-ear pressure for both ears and the mean hearing thresholds for the best ear improved by 166 daPa (p < 0.0001) and 6 dB (p < 0.0001), respectively after four weeks, while in the control group, non-significant alterations were observed. After the cross-over of the control group to treatment, equivalent improvements in the mean middle-ear pressure and the mean hearing thresholds of 187 daPa (p < 0.0001) and 7 dB (p < 0.01), respectively were achieved also in this group. After treatment in both groups at eight weeks, four of 45 children were submitted to grommet surgery. During the long-term follow-up another five children were submitted to surgery due to recurrence of disease. All the children managed to perform the manoeuvre and no side-effects were detected.

Conclusion

The device demonstrated efficiency in improving both middle-ear pressure and hearing thresholds in most children after four weeks of treatment. It might therefore be possible to consider this method of autoinflation in children with persistent OME during the watchful waiting period.

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.

References (23)

  • A. Bidarian-Moniri et al.

    A new device for treatment of persistent otitis media with effusion

    Int. J. Pediatr. Otorhinolaryngol.

    (2013)
  • G.A. Zielhuis et al.

    Screening for otitis media with effusion in preschool children

    Lancet

    (1989)
  • S. Hellstrom et al.

    Tympanostomy tube treatment in otitis media. A systematic literature review. SBU summary and conclusions

    Lakartidningen

    (2008)
  • R. Perera et al.

    Autoinflation for hearing loss associated with otitis media with effusion

    Cochrane Database Syst. Rev.

    (2006)
  • C.D. Bluestone

    Otitis Media in Infants and Children

    (1988)
  • J. Lous et al.

    Grommets (ventilation tubes) for hearing loss associated with otitis media with effusion in children

    Cochrane Database Syst. Rev.

    (2005)
  • Otitis media with effusion, Pediatrics. May 2004;113 (5):...
  • S.E. Stool et al.

    Otitis media with effusion in young children: clinical practice guideline

    (1994)
  • E.M. Mandel et al.

    Eustachian tube function as a predictor of the recurrence of middle ear effusion in children

    The Laryngoscope

    (2013)
  • R. Hunt-Williams

    A method for maintaining middle-ear ventilation in children

    J. Laryngol. Otol.

    (1968)
  • D.D. Reidpath et al.

    Systematic review of autoinflation for treatment of glue ear in children

    BMJ

    (1999)
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