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 Details — Status: Completed

Administrative data

• NCT number: NCT01976819
• Other study ID #: UD788_TW
• Status: Completed
• Phase: N/A
• First received: October 17, 2013
• Last updated: August 10, 2017
• Start date: October 2013
• Est. completion date: April 2014

Study information

• Verified date: August 2017
• Source: Atos Medical AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tracheostomy

Intervention

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.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Atos Medical AB

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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)
Primary	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)