NCT01976819

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Atos Medical AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Tracheostomy

Interventions

Type	Name	Description
DEVICE	TW speaking valve/HME	The TW speaking valve with HME will be used during the day, whereas during sleep patients will use an HME without an automatic speaking valve. Data from TW15 and TW22 will be combined.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2013-11-06
• Last updated: 2017-08-11
• Results posted: 2017-08-11

Locations

1 site across 1 country: Netherlands