N/A
N=16
Clinical Assessment of New Speaking Valve With Heat and Moisture Exchanger (HME) for Tracheotomized Patients
Tracheostomy
Bottom Line
View on ClinicalTrials.gov: NCT01976819 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: 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. — 0.5; 1.1; 2.3; 2.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TW speaking valve/HME (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Atos Medical AB
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
0.5; 1.1; 2.3; 2.3 | — |
| PRIMARY Hours of HME Use Per Day. |
13.5; 14.1 | — |
| PRIMARY Device Preference Rating. |
8.4; 6.5 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01976819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.