Tracheostomy Clinical Trial
Official title:
Phase 2 Clinical Feasibility Study of a New Speaking Valve With a Heat- and Moisture Exchanger (TW) for Tracheotomized Patients.
Verified date | August 2017 |
Source | Atos Medical AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Center Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
Atos Medical AB |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. |
3 weeks including Baseline, week 1, 2 (old device) and week 3 (updated device). | |
Primary | 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) | |
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. | Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device) |
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