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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TW speaking valve/HME | Experimental | Use of the TW speaking valve/HME |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. | 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. | 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. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernardus FA van der Laan, PhD, MD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | 9700RB | Netherlands |
Anonymous (de-identified) patient data will be used for publication, expected 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | TW Speaking Valve/HME | At baseline, participants were asked to complete a baseline questionnaire. After that, patients were asked to use both the current (old) TW15 or the TW22 for a week. After each week, patients completed a device specific questionnaire. At the end of the two week period, patients also completed a structured and comparative questionnaire. Patients were then asked to use the new updated Speaking Valve for a week and then to complete relevant sections of the same questionnaire that was also used for the previous (old) device. Patients could decide again whether they wanted to participate in the long term part of the study, which will follow the same structure with the same questionnaires as in Stage 0. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | TW Speaking Valve/HME | Use of the TW speaking valve/HME 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 3 weeks including Baseline, week 1, 2 (old device) and week 3 (updated device). |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TW Speaking Valve/HME | Use of the TW speaking valve/HME 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| stoma irritation | Skin and subcutaneous tissue disorders | stoma irritation occurred when twisting device |
small sample size;
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Bernard F.A.M. van der Laan, PhD, MD | University Medical Center Groningen and University of Groningen | 0031 (50) 361 27 00 | b.f.a.m.van.der.laan@umcg.nl |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Use of the updated speaking valve/HME
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 22 combined.
| OG001 | Use of the Old HME Speaking Valve | Data from the use of the old HME speaking valve, data from TW15 and TW22 combined. |
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| Primary | Hours of HME Use Per Day. | The mean number of hours of TW use per 24 hours was calculated. | Posted | Mean | Standard Deviation | hours per day | Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device) |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device) |
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| 0 |
| 16 |
| 2 |
| 16 |
| sound leakage past cannula | Surgical and medical procedures | sound leakage past cannula when coughing |
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