Phase 2 clinical feasibility study of a new Speaking Valve with a heat- and moisture exchanger (TW) for tracheotomized patients.
- Conditions
- tracheostomyairway openingTracheotomy10046304
- Registration Number
- NL-OMON38448
- Lead Sponsor
- Atos Medical AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
• is 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.
• is 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 than100 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Exploratory - none. Exploratory parameters are: lungfunction (cough, mucus),<br /><br>breathing, aspiration, speaking, olfaction, use, maintenance and overall<br /><br>statisfaction of the patients.</p><br>
- Secondary Outcome Measures
Name Time Method <p>N.A.</p><br>