de Kleijn B J, van As-Brooks C J, Wedman J, van der Laan B F A M
Department of Otorhinolaryngology-Head & Neck Surgery University of Groningen, University Medical Center Groningen Groningen the Netherlands.
Department of Head and Neck Surgical Oncology Netherlands Cancer Institute Amsterdamthe Netherlands.
Laryngoscope Investig Otolaryngol. 2017 Nov 27;2(6):453-458. doi: 10.1002/lio2.124. eCollection 2017 Dec.
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.
A non-randomized, prospective single center feasibility study.
Sixteen 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.
The device was well-tolerated. Speaking noise was reduced ( = 0.020) and speech was considered to sound more natural compared to previously used devices according to the users ( = 0.020). Overall 11 participants preferred the DualCare to their standard device. No serious adverse events were reported.
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 improve quality of life of tracheotomized patients.
2b.
本研究旨在评估ProTrach DualCare（瑞典霍尔比阿托斯医疗公司）的临床可行性，该设备结合了免提发声阀和热湿交换器（HME），用于气管切开患者。
一项非随机、前瞻性单中心可行性研究。
纳入16例成年气管切开患者。参与者被要求在继续正常活动的同时，使用DualCare两周。两周后，参与者可以选择是否参与长期评估。使用了欧洲五维健康量表（EuroQOL-5D）、博格量表以及关于发声、肺功能和患者偏好的问卷。在长期评估期间，进行了一次小的重新设计，所有参与者被要求再次测试新设备一周，并进行潜在的长期评估。11人决定参与。
该设备耐受性良好。发声噪音降低（P = 0.020），根据用户反馈，与之前使用的设备相比，语音听起来更自然（P = 0.020）。总体而言，11名参与者更喜欢DualCare而不是他们的标准设备。未报告严重不良事件。
总体而言，16名参与者中有11人更喜欢DualCare而不是他们的标准发声阀或HME。DualCare的用户能够免提发声，同时具有HME的优点，该设备被认为在临床上可行，并且有可能改善气管切开患者的生活质量。
2b。
