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

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

patient unable to handle or remove the device him/herself when needed, e.g. has decreased level of cognition or reduced mobility of the arms and/or hands
is mechanically ventilated in any way
has a tidal volume of less than 100 ml
is suffering from severe aspiration
is laryngectomized: the device will block the possibility to exhale if speaking mode is unintentionally activated
has severe upper airway obstruction, this may cause air trapping
has thick and copious secretions which might block the device

Arm && Interventions

Group	Intervention	Description
TW speaking valve/HME	TW speaking valve/HME	Use of the TW speaking valve/HME

Primary Outcome Measures

Name	Time	Method
Evaluate Patient Experiences Associated With Exposure to the Speaking Valve With a Heat- and Moisture Exchanger (TW) for Tracheotomized Patients Based on Results From Questionnaires.	3 weeks including Baseline, week 1, 2 (old device) and week 3 (updated device).	Patients were asked to use either the old TW15 and the TW22 HME device for a week, data combined for the two devices (the device used was recorded). After each week, patients completed a device specific questionnaire (Borg Scale). After the re-design (ie Updated speaking valve), patients were asked to use the new Speaking Valve for a week and then to complete relevant sections of the same questionnaire. Both at baseline and in the follow-up, patients were asked about their breathing using a Borg scale at a particular moment. This scale has a range from 0-6 where a score close to "0" indicates less breathing problems.
Hours of HME Use Per Day.	Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device)	The mean number of hours of TW use per 24 hours was calculated.
Device Preference Rating.	Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device)	Patients were asked to rate the devices on a scale from 0-10, where "10" indicates the best score and "0" the worst score. The overall mean satisfaction with the speaking valve was rated.