Short-term clinical feasibility of a new Speaking Valve with a heat- and moisture exchanger (TW22) for tracheotomized patients.
Completed
- Conditions
- tracheostomyairway openingtracheotomy
- Registration Number
- NL-OMON37865
- Lead Sponsor
- Atos Medical AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
Inclusion Criteria
18 years or older;
have a tracheostomy;
sufficient cognitive ability for handling the TW22;
sufficient manual dexterity for handling the TW22;
are spontaneously breathing;
Have a tidal volume of 250 ml or more;
have a cuffless tracheostomy tube
have a tracheostomy tube with inner- and outer cannula;
have an inner tube with a 22mm connector;
are currently using an HME and/or Speaking Valve;
adequate upper airway.
Exclusion Criteria
use of a too wide non fenestrated tube that does not allow air passage around the tube;
laryngectomized;
mechanically ventilated;
severe airway obstruction;
severe aspiration;
thick and copious secretions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The design of the study is in line with the early nature of the investigation<br /><br>and is observational. There are no specific outcome measures or endpoints.<br /><br>The parameters that are assessed are in line with the parameters that have been<br /><br>reported in the literature to possibly be affected by the use of an HME or<br /><br>Speaking Valve by tracheotomized patients (speaking, breathing, pulmonary<br /><br>symptoms, swallowing, olfaction).</p><br>
- Secondary Outcome Measures
Name Time Method <p>N.A.</p><br>