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

N/ACompletedNCT01976819

Atos Medical AB16 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Tracheostomy

Interventions

TW speaking valve/HMEDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Medical Center Groningen

Groningen, Netherlands

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device)

Data from ClinicalTrials.gov

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