Introduction
To prevent or diminish pulmonary problems in laryngectomized patients, continuous use of a heat and moisture exchanger (HME) is recommended. Therefore, automatic speaking valves are also often combined with an HME to enable hands-free speech. In order to keep these devices in place, most commonly, peristomal patches are used.
Objective
This prospective clinical 2 × 2 crossover study aims at assessing the added value of a new patch for HME application, the Provox StabiliBase OptiDerm (SBO). The device combines the stable and conical base of the Provox StabiliBase with the skin-friendlier hydrocolloid Provox OptiDerm (OD) patch.
Methods
Thirty-two laryngectomized patients were included in this multicenter study. Participants were asked to compare SBO to OD, and to the patch they normally use. The primary outcome measure was patient preference.
Results
Overall, 60% of the participants had preference for their normally used patch, 23% preferred the SBO and 17% indicated no preference. When comparing the SBO to the OD, 43% preferred the SBO, 40% the OD and 17% had no preference.
Conclusion
Most patients preferred their normally used patch and SBO was favored by a subgroup. Provox StabiliBase OptiDerm seems to be a valuable addition to the existing patches and further increases patients' options for HME application.
The aim of this study was to evaluate the clinical feasibility of the ProTrach® DualCare™ (Atos Medical, Hörby, Sweden), a device combining a hands free speaking valve and a Heat and Moisture Exchanger (HME) for tracheotomized patients.Study Design: A non-randomized, prospective single center feasibility study.Methods: 16 adult tracheotomized patients were included. Participants were asked to test the DualCare™ for two weeks, while continuing their normal activities. After these two weeks, participants could choose whether or not to take part in the long-term evaluation. The EuroQOL-5D, Borg scale and questionnaires on speaking, pulmonary function and patient preference were used. During the long term evaluation, a minor redesign was implemented and all participants were asked to test the new device again for one week, with a potential long term evaluation.Eleven decided to participate.
Results:The device was well-tolerated. Speaking noise was reduced (p=0.020) and speech was considered to sound more natural compared to previously used devices according to the users (p=0.020). Overall 11 participants preferred the DualCare™ to their standard device. No serious adverse events were reported.
Conclusion:Overall 11 of 16 participants preferred the DualCare™ to their standard speaking valve or HME. Users of the DualCare™ were able to use hands free speech with the benefits of an HME and the device was considered clinically feasible and has the potential to improved quality of life of tracheotomized patients.
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