Tracheostomy
Conditions
Keywords
Tracheotomy, Tracheostomy, Speaking valve, HME, patients
Brief 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.
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.
Interventions
DEVICETW 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.
Sponsors
Atos Medical AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. | 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. | 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. |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | TW Speaking Valve/HME |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 58.50 years STANDARD_DEVIATION 12.85 |
| Region of Enrollment Netherlands | 16 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
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.
Time frame: Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Updated Speaking Valve/HME | Device Preference Rating. | 8.4 units on a scale | Standard Deviation 1.5 |
| Use of the Old HME Speaking Valve | Device Preference Rating. | 6.5 units on a scale | Standard Deviation 2.5 |
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.
Time frame: 3 weeks including Baseline, week 1, 2 (old device) and week 3 (updated device).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Updated Speaking Valve/HME | 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. | Breathing with TW follow-up | 0.5 units on a scale | Standard Deviation 0.8 |
| Updated Speaking Valve/HME | 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. | Breathing with TW baseline | 2.3 units on a scale | Standard Deviation 1.9 |
| Use of the Old HME Speaking Valve | 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. | Breathing with TW follow-up | 1.1 units on a scale | Standard Deviation 0.5 |
| Use of the Old HME Speaking Valve | 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. | Breathing with TW baseline | 2.3 units on a scale | Standard Deviation 1.9 |
Primary
Hours of HME Use Per Day.
The mean number of hours of TW use per 24 hours was calculated.
Time frame: Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Updated Speaking Valve/HME | Hours of HME Use Per Day. | 13.5 hours per day | Standard Deviation 2.7 |
| Use of the Old HME Speaking Valve | Hours of HME Use Per Day. | 14.1 hours per day | Standard Deviation 2.3 |