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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tracheostomy

Intervention / Treatment
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* Device: TW speaking valve/HME


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older has a tracheostomy is spontaneously breathing has a cuffless tracheostomy tube has a tracheostomy tube with inner and outer cannula currently uses an HME and/or speaking valve 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TW speaking valve/HME<br>Use of the TW speaking valve/HME | Device: TW speaking valve/HME<br>* 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.<br>* Other names: DualCare speaking valve/HME;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3 weeks including Baseline, week 1, 2 (old device) and week 3 (updated device). | 
| Hours of HME Use Per Day. | The mean number of hours of TW use per 24 hours was calculated. | Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device) | 
| Device Preference Rating. | 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. | Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tracheotomy, Tracheostomy, Speaking valve, HME, patients