Otovent nasal balloon for otitis media with effusion

Study component

Description

Objectives/hypotheses

To study the efficacy of nasal balloon auto‑inflation in children with otitis media with effusion in primary care.

Study design

Open randomised controlled trial with 2 arms: auto‑inflation with standard care, and standard care alone. Standard care was not described further.

Setting

43 family practices from 17 primary care trusts in the UK between January 2012 and February 2013.

Inclusion/exclusion criteria

Children were eligible for inclusion if they were attending school and aged 4 to 11 years; had a history of hearing loss or other relevant ear‑related problems in the past 3 months; and had objective otoscopic and tympanometric confirmation of otitis media with effusion in at least 1 ear.

Children were excluded if they had current clinical features of acute otitis media (such as ear pain, fever or otoscopic features of acute inflammation); recent or planned ear surgery; a known latex allergy; or a recent nosebleed.

Primary outcomes

The difference between the intervention and control groups in the proportion of children showing definite tympanometric resolution of pressure in at least 1 affected ear at 1 month.

Secondary outcome

Ear related quality of life using OMQ‑14.

Statistical methods

Modified intention to treat analysis. The relative effect of auto‑inflation on the primary outcome at 1 month and at 3 months was estimated using a generalised linear model for binary data with log‑link function, and adjusted for baseline covariates (tympanometric baseline severity, age, sex and primary care trust).

Patients included

320 school children aged 4 to 11 years with glue ear in at least 1 ear.

Results

Of the 320 children enrolled, those having auto‑inflation were more likely than controls to have normal tympanograms at 1 month and at 3 months.

Conclusions

Auto‑inflation in children aged 4 to11 years with otitis media with effusion is feasible in primary care and effective both in clearing effusions and improving symptoms and ear‑related child and parent quality of life.

Abbreviations: OMQ‑14, 14‑point questionnaire on the effect of otitis media with effusion.

Otovent plus standard care

Standard care

Analysis

Number of children

160

160

Primary outcome:

Tympanometric resolution at 1 and 3 months (percentage of children)

1 month:

47.3% (62/131)

1 month:

35.6% (47/132)

1 month: RR 1.36; 95% CI 0.99 to 1.88; p=0.06

3 months:

49.6% (62/125)

3 months:

38.3% (46/120)

3 months: RR 1.37; 95% CI 1.03 to 1.83; p=0.03

Secondary outcome:

Ear‑related quality of life (OMQ‑14 score; mean±SD)

Baseline:

−0.07±1.00 (153/160)

Baseline:

−0.04±0.95 (153/160)

Adjusted between‑group difference in change from baseline in OMQ‑14 score (an ear‑specific quality of life measure) −0.42; 95% CI −0.63 to −0.22; p<0.001

3 months:

−0.70±1.01 (127/160)

3 months:

−0.37±1.06 (121/160)

Compliance

1 month: 89%

3 months: 80%

Not applicable

Not applicable

Patients reporting serious adverse events

No serious adverse events reported

No serious adverse events reported

Not applicable

Abbreviations: CI, confidence interval; OMQ‑14, 14‑point questionnaire on the effect of otitis media with effusion; RR, relative risk; SD, standard deviation.

Study component

Description

Objectives/hypotheses

To assess the effects of using Otovent on children on the waiting list for grommet insertion.

Study design

Randomised controlled trial with 2 arms; auto‑inflation group and observation group.

Setting

Bristol Children's Hospital, UK from July to December 1991, with final follow‑up in March 1992.

Inclusion/exclusion criteria

Children were eligible for inclusion if they were aged 3 to 10 years with confirmed bilateral type B or C2 tympanograms on 2 occasions separated by at least 3 months.

Children were excluded if they had previously been treated by adenoidectomy or tonsillectomy or had chromosomal or craniofacial abnormalities.

Primary outcomes

Improvement in tympanometric findings defined as the number of ears converting from type B or C2 to type A or C1. Type A is classed as normal.

Clearance of fluid on pneumatic otoscopy.

Statistical methods

The tympanometric results were analysed using the Mann–Witney rank sum test. The otoscopy results were analysed using the Chi‑square test.

Compliance was measured as the number of times the device was used as a percentage of the maximum possible.

For analysis, the children in the treatment group were split into a high compliance group (compliance greater than 70%; n=19) and a low compliance group (compliance less than 70%; n=23).

Results were also analysed on an intention‑to‑treat basis.

Patients included

A consecutive series of 85 children meeting the selection criteria was selected from the waiting list for grommet insertion surgery.

Results

Statistically significant improvement was seen in the high compliance group. This was detected on the outcome measures of tympanometry and pneumatic otoscopy after 1, 2 and 3 months.

Conclusions

Auto‑inflation can be an effective short‑term treatment for children with OME when used regularly under supervision.

Abbreviations: OME, otitis media with effusion.

Otovent group

Observation group

Analysis

Number of children

n=42

n=41

166 ears assessed at entry to study.

Primary outcome:

Tympanometric results (Type A or C1 at 1, 2 and 3 months; % of ears)

1 month:

HC: 32.4%¹

LC: 12.5%¹

1 month: 8.9%¹

Statistically significant improvement in the HC group compared with the observation only group at:

No statistically significant difference between the LC and observation only groups.

The analysis by intention to treat showed a significant improvement at 1 month (p<0.01).

2 months

HC: 29%¹

LC: 0%¹

2 months: 13.5%¹

3 months:

HC: 26.4%¹

LC: 2.3%¹

3 months: 5.2%¹

Clearance of fluid on pneumatic otoscopy at 1, 2 and 3 months (% of ears)

1 month:

HC: 47.4% (18/38)

LC: 12.5% (5/46)

1 month:

14.3% (11/82)

Statistically significant improvement in the HC group compared with the observation only group at:

The analysis by intention to treat showed statistically significant improvements at 1 and 2 months (p<0.05).

2 months:

HC: 44.7% (17/38) LC: 7.1% (3/46)

2 months:

10.8% (8/82)

3 months:

HC: 36.8% (14/38)

LC: 4.6% (2/46)

3 months

10.5% (8/82)

Patients reporting serious adverse events

No adverse events reported

No adverse events reported

Not applicable.

Abbreviations: HC, high compliance subgroup; LC, low compliance subgroup.

¹ Calculated by the authors of this briefing.

Study component

Description

Objectives/hypotheses

To evaluate the long‑term effects of auto‑inflation on reducing the need for insertion of ventilation tubes in children with chronic otitis media.

Study design

Randomised control trial with 2 arms; a treatment group having auto‑inflation and nasal saline irrigation, and a control group having only nasal saline irrigation.

Setting

Istanbul, Turkey; January 2002 to April 2004 with 3 month follow‑up.

Inclusion/exclusion criteria

Children with MEE and free of signs of otitis media were included.

Children were excluded if they had any of the following conditions: hypersensitivity or significant adverse reactions to penicillin; previous tonsillectomy or adenoidectomy; previous ear surgery other than tympanocentesis or myringotomy with or without tube insertion; history of seizure disorder, diabetes mellitus, asthma needing daily medication, or any health condition that could make entry potentially dangerous; medical conditions with a predisposition for MEE, such as cleft palate, Down's syndrome, congenital malformations of the ear, cholesteatoma, or chronic mastoiditis; severe retraction pockets; acute or chronic diffuse external otitis; perforation of the tympanic membrane; intracranial or intra‑temporal complications of MEE; upper respiratory obstruction attributable to tonsil or adenoid enlargement or both with cor pulmonale, sleep apnoea, or severe dysphagia; history of varicella exposure within the past 30 days (if never had clinical varicella or varicella vaccine) or clinical varicella within the past 3 weeks; history of measles exposure in the past 30 days; or immunisation within the past 30 days.

Primary outcomes

Surgical insertion of ventilation tubes in the eardrum.

Recovery rate from effusion.

Statistical methods

Chi‑square test.

Patients included

60 children aged 4 to 10 years, diagnosed with chronic otitis media with effusion.

Results

In the auto‑inflation group, there was a statistically significant decrease in the need for the insertion of ventilation tubes compared with the control group at 3, 6 and 9 months.

Conclusions

Auto‑inflation reduces the need for insertion of a ventilation tube, both in the short and long term. Children should be followed as long as they are at risk of recurrence.

Abbreviations: MEE, middle ear effusion.

Otovent plus nasal saline irrigation

Nasal saline irrigation

Analysis

Number of ears

n=48

n=45

Primary outcomes:

Cumulative number of ears requiring ventilation tube insertion after 3, 6 and 9 months

3 months: 37% (18/48)

3 months: 62% (28/45)

3 months: p=0.017

6 months: 43% (20/46)

6 months: 65% (28/43)

6 months: p=0.040

9 months: 43% (20/41)

9 months: 75% (30/40)

9 months: p=0.015

Recovery rates from effusion at 3, 6 and 9 months

3 months: 52% (25/48)

3 months: 31% (14/45)

3 months: p=0.108

6 months: 52% (24/46)

6 months: 45% (16/45)

6 months: p=0.010

9 months: 75% (22/42)

9 months: 20% (8/40)

9 months: p=0.002

Patients reporting serious adverse events

No serious adverse events reported

No serious adverse events reported

Not applicable

Study component

Description

Objectives/hypotheses

To evaluate the effect of auto‑inflation as a treatment option for secretary otitis media.

Study design

Randomised controlled trial with 2 arms; an auto‑inflation group and a control group observed without treatment.

Setting

Ear nose and throat hospital in Denmark; June to December 1988. Two weeks of auto‑inflation with a further 2 weeks if symptoms did not improve. Followed up at 1, 2 and 3 months.

Inclusion/exclusion criteria

Inclusion criteria included unilateral or bilateral secretory otitis media for at least 3 months, and aged between 3 and 10 years.

No exclusion criteria were stated.

Primary outcomes

Tympanometric resolution at 2 weeks, and at 1, 2 and 3 months after study entry.

Statistical methods

Statistical analysis was done using the Mann–Whitney rank sum test.

Patients included

100 children aged 3 to 10 years.

Results

Of 100 children enrolled, those doing auto‑inflation 3 times per day were more likely than controls to have improved tympanograms after 2 weeks of treatment. A statistically significant difference between the treatment and the control groups remained at 1 month but was not apparent at 2 and 3 months.

Conclusions

Children from the age of 3 years may benefit from auto‑inflation. Because of the short‑term nature of the treatment effects, repeated use is necessary.

Otovent

Control

Analysis

Number of children (ears)

n=50 (51)

n=50 (73)

Primary outcomes:

Tympanometric resolution at 2 weeks

Tympanometric conditions improved in 33 (65%¹) ears, unchanged in 17 (33%¹), and deteriorated in the remaining 1 (2%) ear.

Tympanometric conditions improved in 11(15%) of ears, unchanged in 52 (71%), and deteriorated in the remaining 10 (14%).

At 2 weeks, p<0.001.

Tympanometric resolution at 1 month for children who showed no improvement at 2 weeks

n=27 ears

Tympanometric conditions improved in 7 (26%) ears, unchanged in 20 (74%) ears.

n=55 ears

Tympanometric conditions improved in 14 (26%) ears, unchanged in 33 (60%), and deteriorated in the remaining 8 (14%) ears.

At 1 month, p<0.05.

Tympanometric resolution at 2 and 3 months

At 2 months 20.9% had type A or C1 tympanograms.

At 2 months 15.8% had type A or C1 tympanograms.

No significant differences between groups at 2 and 3 months.

At 3 months 17.1% had type A or C1 tympanograms.

At 3 months 14.2% had type A or C1 tympanograms.

Patients reporting serious adverse events

No serious adverse events reported.

No serious adverse events reported.

Not applicable.

¹ The percentages were recorded incorrectly in the abstract. These are the values recorded in the results section of the paper. These have been verified by the authors of this briefing based on the numbers given in the paper.