Phase 2 clinical feasibility study of a new Speaking Valve with a heat- and moisture exchanger (DualCare) for tracheotomized patients

Abstract

But de la presentation Tracheotomized patients lack the function of the upper airway moisturizing, warming and filtering air. Furthermore they are unable to speak without occluding the cannula. Heat and Moisture Exchangers (HME) and hands-free speaking valves are developed to aid patients. The Protrach DualCare (Atos Medical, Horby, Sweden) is the first device combining a fully functional HME and hands-free speaking valve for tracheotomized patients. This study is performed to determine the clinical feasibility of the Dualcare. Materiel et methodes A prospective feasibility study with 16 tracheotomized patients was performed in the UMCG. During two weeks the DualCare was tested with a 15 and/or 22 mm HME. After redesign the DualCare was tested again by 11 patients during one week. Questionnaires consisted of the EQ5D, Borg scales and device/disease specific questionnaires covering among others pulmonary function and speech aspects. Resultats Patients tolerated the device well. Speaking noise is less and speech is more natural compared to their previous device. One patient was excluded from preference analysis due to recurrent disease and canula problems. After the first period 10 of 15 patients preferred the DualCare, after the second period all 11 patients. There were no Serious Adverse Events. Registered Device Deficiencies were mainly due to stickiness of the membrane. After the redesign these were solved. Conclusion The DualCare is safe in use. Overall 11 of 15 patients preferred the DualCare. This is 100 % of patients testing the redesign. Patients benefit from the HME while being able to employ hands-free speech. The ProTrach DualCare is clinically feasible.