Development and Clinical Assessment of a Heat and Moisture Exchanger with a Multi-magnet Automatic Tracheostoma Valve (Provox FreeHands HME) for Vocal and Pulmonary Rehabilitation after Total Laryngectomy

Abstract

Objective--To develop and test the prototypes of a novel post-laryngectomy rehabilitation tool incorporating an obligatory, disposable heat and moisture exchanger (HME) and a reusable, multi-magnet automatic speaking valve (ASV).Material and methods--The study subjects comprised 20 laryngectomized individuals (15 males, 5 females), 5 of whom were already using an ASV and 15 who were not. Three successive prototypes were tested. Data were collected by means of structured questionnaires, considering for example patient compliance, skin adhesion, voicing and coughing aspects, and voice and speech quality assessments, assessing for example maximum phonation time and dynamic loudness range.Results--Of the 15 non-ASV users, 5 did not comply with the study due to peristomal skin adhesion problems. Of the remaining 15 patients, all 5 ASV users and 6/10 non-users were fully compliant with the new device. The cough-relief valve of the new device functions properly, as does the valve position adjustment for physical exertion. With this new device the maximum phonation time was longer than with a regular ASV (15.2 vs 11.6 s; p=0.006) and the dynamic range was larger (33.0 vs 24.8 dB; p<0.001).Conclusion--The test results obtained with this new device show that its advanced features (obligatory HME and multi-magnet valve systems) offer additional benefits for further improving vocal and pulmonary rehabilitation after total laryngectomy.