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Completed

NCT Number: NCT01976819

Clinical Assessment of New Speaking Valve With Heat and Moisture Exchanger (HME) 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.

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Key information

Conditions

Tracheostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, 9700RB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TW speaking valve/HME

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Atos Medical AB

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 6, 2013
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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