tracheostomy airway opening Tracheotomy
Conditions
Interventions
The use of the TW device for a period of 2 weeks, with the option to continue
using it until 3 months. After these three months, patients can continue to use
the device for a total of one year if th
Sponsors
Atos Medical AB
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exploratory - none. Exploratory parameters are: lungfunction (cough, mucus), breathing, aspiration, speaking, olfaction, use, maintenance and overall statisfaction of the patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| N.A. | — |
Countries
Netherlands
Outcome results
None listed