Development and evaluation of a novel tracheostoma button and fixation system (Provox LaryButton and LaryClip adhesive) to facilitate hands-free tracheoesophageal speech

Abstract

Conclusion: This newly developed tracheostoma button and fixation system was appreciated by the majority of the patients in this study and led to an increased use of automatic speaking valves (ASVs).

Objective: Development and prospective clinical evaluation of a new tracheostoma button and fixation system to enhance hands-free speech in laryngectomized patients.

Patients and methods: The Provox LaryButton and LaryClip adhesive system were prospectively evaluated in 11 patients: 10 male, 1 female; mean age 60.5 years, range 46-80 years; median follow-up since laryngectomy 4.9 years, range 9 months to 21 years. A study-specific questionnaire was used and the observation period was 3 weeks.

Results: Eight patients were compliant, three dropped out of the study. The LaryClip adhesive system was tried by seven of these compliant patients, and ultimately used by six. At the start of the study two patients used an ASV on a daily basis, three alternated between an ASV and regular, manually operated heat and moisture exchangers (HME), three only used a HME. At the end of the study, three used the ASV daily, five alternated between ASV and HME. Seven patients indicated that they would continue using the new system, six with clips and one with the button only.