Trial Outcomes & Findings for Clinical Assessment of New Speaking Valve With Heat and Moisture Exchanger (HME) for Tracheotomized Patients (NCT NCT01976819)
NCT ID: NCT01976819
Last Updated: 2017-08-11
Results Overview
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.
COMPLETED
NA
16 participants
3 weeks including Baseline, week 1, 2 (old device) and week 3 (updated device).
2017-08-11
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Assessment of New Speaking Valve With Heat and Moisture Exchanger (HME) for Tracheotomized Patients
Baseline characteristics by cohort
| Measure |
TW Speaking Valve/HME
n=16 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
|
Age, Continuous
|
58.50 years
STANDARD_DEVIATION 12.85 • n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
|
Region of Enrollment
Netherlands
|
16 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Updated Speaking Valve/HME
n=11 Participants
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.
|
Use of the Old HME Speaking Valve
n=16 Participants
Data from the use of the old HME speaking valve, data from TW15 and TW22 combined.
|
|---|---|---|
|
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
|
1.1 units on a scale
Standard Deviation 0.5
|
|
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
|
2.3 units on a scale
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Updated Speaking Valve/HME
n=11 Participants
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.
|
Use of the Old HME Speaking Valve
n=16 Participants
Data from the use of the old HME speaking valve, data from TW15 and TW22 combined.
|
|---|---|---|
|
Hours of HME Use Per Day.
|
13.5 hours per day
Standard Deviation 2.7
|
14.1 hours per day
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Updated Speaking Valve/HME
n=11 Participants
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.
|
Use of the Old HME Speaking Valve
n=16 Participants
Data from the use of the old HME speaking valve, data from TW15 and TW22 combined.
|
|---|---|---|
|
Device Preference Rating.
|
8.4 units on a scale
Standard Deviation 1.5
|
6.5 units on a scale
Standard Deviation 2.5
|
Adverse Events
TW Speaking Valve/HME
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TW Speaking Valve/HME
n=16 participants at risk
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
|
|---|---|
|
Skin and subcutaneous tissue disorders
stoma irritation
|
6.2%
1/16 • Number of events 1
|
|
Surgical and medical procedures
sound leakage past cannula
|
6.2%
1/16 • Number of events 1
|
Additional Information
Prof. Dr. Bernard F.A.M. van der Laan, PhD, MD
University Medical Center Groningen and University of Groningen
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place