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Clinical Assessment of New Speaking Valve With Heat and Moisture Exchanger (HME) for Tracheotomized Patients

Tracheostomy Clinical Trial

Official title:
Phase 2 Clinical Feasibility Study of a New Speaking Valve With a Heat- and Moisture Exchanger (TW) for Tracheotomized Patients.

Clinical Trial Summary

This clinical investigation addresses the performance of a re-designed The current study aims to investigate the next version of the TW speaking valve, in combination with both a 15mm and 22mm HME cassette.

Clinical Trial Description

This clinical investigation addresses the performance of a re-designed (updated) speaking valve with Heat and Moisture Exchangers (HME) for tracheotomized patients (project development name 'TW', commercial name 'DualCare'). Study participants trial the new device for 2 weeks after which they can choose to discontinue using the device or continue in the 3 month follow-up part of the study. Clinical feasibility is assessed using structured questionnaires addressing voice and speech, quality of life, breathing, swallowing, olfaction, sleeping, and respiratory symptoms. This is an exploratory, observational study and no specific hypotheses have been formulated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01976819
Study type Interventional
Source Atos Medical AB
Contact
Status Completed
Phase N/A
Start date October 2013
Completion date April 2014
View Details
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