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

August 10, 2017 updated by: Atos Medical AB

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700RB
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TW speaking valve/HME
Use of the TW speaking valve/HME
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.
Other Names:
  • DualCare speaking valve/HME

What is the study measuring?

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.
Time Frame: 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.
3 weeks including Baseline, week 1, 2 (old device) and week 3 (updated device).
Hours of HME Use Per Day.
Time Frame: 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.
Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device)
Device Preference Rating.
Time Frame: 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.
Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atos Medical AB

Investigators

  • Principal Investigator: Bernardus FA van der Laan, PhD, MD, University Medical Center Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

October 17, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimate)

November 6, 2013

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 10, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UD788_TW

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Anonymous (de-identified) patient data will be used for publication, expected 2016.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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