Practicability of the Provox® FreeHands FlexiVoicein Automatic Tracheostomy Valve in Clinical Practice

Introduction The use of tracheoesophageal voice prostheses helps 80 % of laryngectomized patients to achieve a sufficient replacement voice. For phonation, the tracheostoma usually has to be closed manually. Automatic tracheostomy valves (ATV) are an alternative, but their acceptance is limited. We investigated this problem for the ATV FreeHands FlexiVoice® (FV) with integrated Heat and Moisture Exchanger (HME) Provox.

Methods and Patients In a prospective long-term study (6 months) with 20 volunteers, the use of the FV in Germany was examined for the first time. Long-term compliance was defined as the primary goal. Secondary objectives were, among others, frequency of use, service life and functional life of the tracheostomy patch.

Results After six months, 80 % (50 % daily, 30 % not daily) of the subjects used the FV. The active hands-free speaking time (2.23 ± 1.54 h/d vs. 1.25 ± 0.89 h/d), but not the duration of use (7.5 ± 3.3 h/d vs. 5.2 ± 4.4 h/d), differed significantly between daily and nondaily users. The main reasons for limited FV use were mounting problems and increased breathing resistance. The voice and speech measurement according to objective criteria showed no significant deterioration in the use of the FV compared to an HME.

Conclusion Compared to other ATVs, the FV showed higher long-term compliance, indicating better practicability. However, the frequency and length of ATV use hardly improved in comparison with FV use. The active hands-free talk time used for the first time in the present study as a measure of ATV practicability is a suitable tool for future studies.

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Publication History

Article published online:
10 June 2020