Laryngectomy removal of larynx
Conditions
Interventions
The study will consist of two periods of four weeks with multiple data
collection points. In the first period of four weeks, patients will document
their usual use of attachments and HMEs. After the
Sponsors
Atos Medical AB
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Total laryngectomy 18 years or older HME user Longer than 3 months after total laryngectomy or postop radiotherapy
Exclusion criteria
Exclusion criteria: Medical problems prohibiting the use of HME or adhesive Active recurrent or metastatic disease (medical deterioration) Reduced mobility of arms and/or hands, unable to remove an HME Unable to understand the Patient Information and/or unable to give Informed Consent Insufficient cognitive ability to handle the HME or adhesive Use of LaryTube during night on medical prescription (e.g. shrinking stoma) Too low tidal volume as this may cause carbon dioxide retention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is compliant use of the HME. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures for the Provox Luna Adhesive are performance (stickiness, comfort, cooling and soothing of the skin, visibility of the skin) and skin effects (healing/recovering of skin, severity and frequency of skin irritation and pain reduction). The secondary outcome measures of the Provox Luna HME are performance (breathing, speaking, comfort of the device), pulmonary effects (coughing, forced expectorations, tracheal irritation, mucus production) and Quality of Life (sleeping, EQ-5D). Overall satisfaction with Provox Luna (both the adhesive and the HME) is also a secondary outcome measure. | — |
Countries
Netherlands
Outcome results
None listed