NL-OMON38448
Completed
Phase 2
Phase 2 clinical feasibility study of a new Speaking Valve with a heat- and moisture exchanger (TW) for tracheotomized patients. - Clinical feasibility of the TW
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- tracheostomy
- Sponsor
- Atos Medical AB
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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