Complications with the use of Bivona adjustable flange tracheostomy tube.

Abstract

We wish to report two issues that we recently identified following the insertion of a Bivona (Smiths Medical, Ashford, UK) tracheostomy tube which developed recurrent leakage due to cuff deflation. In the first instance, the pilot balloon and cuff were both slowly deflating and required repeated re-inflation. In the second instance (with the same tube), the pilot balloon pressure was elevated, but the cuff continued to have a sizeable leak. On removal and examination of the tube, no structural damage was noted, but the cause for both incidents was identified. The Bivona tracheostomy tube was surgically inserted, and the cuff balloon was initially inflated with air and a good seal was achieved. However, we found a gradual and consistent loss of cuff pressure leading to a loss of tidal volume. The cuff was then re-inflated with air via the pilot balloon and although this resolved the issue temporarily, the cuff leak recurred and the cuff pressure was checked and indicated to be less than 20 cmH2O. Assuming this could be due to tube migration, the adjustable flange clip was released and the tube was inserted 1 cm further down the stoma site and the clip was reconnected to its position. The cuff was inflated with air; however, this manoeuvre did not resolve the issue of air leak; examination of the cuff pressure showed a pressure of between 80 and 90 cmH2O. The Bivona tracheostomy tube was changed to a conventional size 9.0 Portex (Smiths Medical, Ashford, UK) tube and ventilation improved. Following the removal of the Bivona tracheostomy tube, we had a thorough examination of the tube and found no structural defect or damage to the tube. However, we did find the reasons for the initial cuff leak and the unexpected high cuff pressure.