Can you use a party balloon instead of an autoinflation balloon to treat glue ear?

Problem

Autoinflation balloons can be used to help avoid the need for surgery in otitis media with effusion. We tested Otovent® autoinflation balloons to determine how many times they could produce a pressure of 40mmHg (the pressure required for a Valsalva manoeuvre). We also tested four other ‘party balloons’ to determine whether these were also able to produce adequate pressures.

Approach

Using an Omron PA350e pressure monitor we inflated each balloon 20 times and measured the maximum pressure reached each time using video recording of the display. Three balloons of each type were tested to 50 inflations to assess pressures over persistent use. The party balloons were selected to ensure a range of shapes and manufacturers were tested. We tested 8 Otovent® balloons, and 10 balloons of each of 4 different types (two spherical types, one modelling type, and one long spiral type). Following this, we carried out a pilot clinical trial of 12 healthy participants to test the effectiveness of the two spherical balloons in comparison to Otovent® balloons. Participants blew up each balloon in turn with the same nostril and reported whether or not their ears ‘popped’ (a measure of a successful Valsalva manoeuvre).

Findings

The mean inflation pressure for the eight Otovent® balloons was 92.9mmHg (95% CI 88.9-96.8%mmHg) on the first inflation, dropping to 82.7mmHg (95%CI 79.6-85.7mmHg) after 20 inflations, and 77.4mmHg (95%CI 74.0-80.8mmHg) after 50 inflations. Sphere balloon 1 required a mean inflation pressure of 83.6mmHg (95%CI 77.3-90.0mmHg) on the first inflation, 74.0mmHg (95% CI 67.5-80.5mmHg) after 20 inflations, and 71.2mmHg (95% CI 66.5-75.9mmHg) after 50 inflations. Sphere balloon 2 required a mean inflation pressure of 107.7mmHg (95%CI 96.5-118.9mmHg) on the first inflation, 82.6mmHg (95% CI 77.3-87.9mmHg) after 20 inflations, and 77.1mmHg (95% CI 67.8-86.4mmHg) after 50 inflations. Modelling balloons (long and thin) were found to require excessively high inflation pressures, with four not inflating even at the maximum of 300mmHg and the others still requiring a mean pressure of 278.1mmHg. Long spiral balloons were found to inflate in an irregular fashion due to their shape, and had an unpredictable and variable pressure response during inflation, making their results unreliable.Participants reported a 66.7% (95%CI 40.0-93.3%) success rate of a Valsalva manoeuvre when using both the Otovent® balloons and sphere balloon 2 whilst with sphere balloon 1 a 58.3% (95%CI 30.4-86.2%) success rate was reported.

Consequences

Otovent® balloons can be reused more than the initial 20 times quoted by the manufacturer. The two spherical balloons tested produced similar pressures to the Otovent® balloons, indicating that they may be capable of producing the same clinical effect. The pilot clinical trial further suggests the potential for spherical party balloons to be used in place of Otovent® as treatment for OME.