TracheostomyNCT01976819

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

A study testing TW speaking valve/HME in people with Tracheostomy, run by Atos Medical AB at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Tracheostomy
What is being tested?: TW speaking valve/HME
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteNetherlands
Study dates: Oct 2013to Apr 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

University Medical Center Groningen
Groningen, 9700RB

Other trials in Netherlands

About this study

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

Read the 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.

Conditions: Tracheostomy
Being tested: TW speaking valve/HME
Keywords: Tracheotomy, Tracheostomy, Speaking valve, HME, patients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TW speaking valve/HMEDevice
Also called DualCare 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.

Study groups in NCT01976819
Study group	Role	What they receive
TW speaking valve/HME	Experimental	Use of the TW speaking valve/HME Receives: Device: TW speaking valve/HME

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Apr 2014

First posted6 Nov 2013 (estimated)
Study startOct 2013
Primary completionApr 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for TracheostomyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01976819
Sponsor's protocol ID: UD788_TW
Status last verified: Aug 2017
First submitted: 17 Oct 2013
Last updated: 11 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Anonymous (de-identified) patient data will be used for publication, expected 2016.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Classical Music, Pain, and Physiological Parameters in Children Undergoing Two Aspiration Procedures
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All Tracheostomy trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Clinical Feasibility Study of a New Speaking Valve With a Heat- and Moisture Exchanger (TW) for Tracheotomized Patients.
ClinicalTrials.gov ID: NCT01976819
Acronym / sponsor ID: UD788_TW
Conditions: Tracheostomy
Keywords: Tracheotomy, Tracheostomy, Speaking valve, HME, patients
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Atos Medical ABIndustry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 6 Nov 2013 (estimated)
Results: Posted 11 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TW speaking valve/HME	Experimental	Device: TW speaking valve/HMEUse of the TW speaking valve/HME

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

18 years or older
has a tracheostomy
is spontaneously breathing
has a cuffless tracheostomy tube
has a tracheostomy tube with inner and outer cannula

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TW speaking valve/HMEAlso: DualCare speaking valve/HMEThe 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.	Device	TW speaking valve/HME

Primary outcome

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.
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.
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.

Results and safety

Results posted to the registry on 11 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TW Speaking Valve/HME	16	11

Primary outcome: 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).. Mean (Standard Deviation). Unit: units on a scale

Measure	Updated Speaking Valve/HME n = 11	Use of the Old HME Speaking Valve n = 16
Breathing with TW follow-up	0.5 (0.8)	1.1 (0.5)
Breathing with TW baseline	2.3 (1.9)	2.3 (1.9)

Primary outcome: Hours of HME Use Per Day.

Time frame: Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device). Mean (Standard Deviation). Unit: hours per day

Measure	Use of Updated Speaking Valve n = 11	Use of Old Speaking Valve n = 16
Value	13.5 (2.7)	14.1 (2.3)

Primary outcome: Device Preference Rating.

Time frame: Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device). Mean (Standard Deviation). Unit: units on a scale

Measure	Use of Updated Speaking Valve n = 11	Use of Old Speaking Valve n = 16
Value	8.4 (1.5)	6.5 (2.5)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TW Speaking Valve/HME	0 of 16 (0%)	2 of 16 (12.5%)	Not reported

Limitations and caveats (from the sponsor): small sample size;

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Anonymous (de-identified) patient data will be used for publication, expected 2016.

Related trials for Tracheostomy

Not yet recruitingObservational study
A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients
Stroke Patients, Tracheostomy
Enrolling by invitationObservational study
A Speaking-Valve-Based Decannulation Protoco for Patients With a Prolonged Disorders of Consciousness
Prolonged Disorders of Consciousness, Tracheostomy
Not yet recruitingObservational study
Laryngotracheal Lesions in Adults With Long-Term Tracheostomy
Laryngotracheal Lesions, Tracheostomy Complications
Enrolling by invitation
No DIET Trial: Dogmatic Interruption of Enteral nuTrition
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Recruiting
Classical Music, Pain, and Physiological Parameters in Children Undergoing Two Aspiration Procedures
Endotracheal Aspiration, Tracheostomy Patients

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bernardus FA van der Laan, PhD, MD principal investigator

University Medical Center Groningen

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TW speaking valve/HME in people with Tracheostomy, run by Atos Medical AB at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01976819.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.