Z93.0
Conditions
Interventions
Group 1: At the day of randomisation the patients will be supplied with HME-Filters, which shall be used continuously until the end of trial after six months. The filter will be changed by the patient
Sponsors
Atos Medical GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients following a complete laryngectomy more than six months ago (voice rehabilitation by a voice prothesis welcome, but not required) - so far no usage of HME-Filters - >= 18 years of age - written informed consent
Exclusion criteria
Exclusion criteria: - intense mucus production - bleedings of the lower respiratory tract (lung, bronchii, trachea) - inability to change the HME-filter by themselves (e. g. hand or arm problems, coordination deficits) - acking compliance - participation in other interventional trials - physical, mental or other inability to supply required information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of coughing attacks within one week at the time point six months after randomization - determined by the patient's diary. | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of coughing attacks three months after randomisation as documented in the patients diary for the week before visit T3 || Bronchial mucus production three and six months after randomisation according to the documented number of forced coughing up in the patient's diary for the week before the visit. || Lung function three and six months after randomisation. Determined will be vital capacity, FEV1 and FIV1, PEF and PIF, MEF50 and MIF50 and total lung capacity (TLC) resulting from a lung function test. || Quality of life three and six months after randomisation, evaluated by patient questionnaires filled in at the visits after three and six months respectively. || Occurence of tracheitis within the trial period of six months Assessment by bacterial swab tests of the throat at the trial visits || Interrelation between respiratory distress symptoms (coughing, mucus production, shortness of breath) and overall symptoms (tiredness, sleep disorders, anxieties, depression) Combined analysis of the different questionnaires and diaries over the course of the trial. || Cost effectiveness of the different treatment arms, determined by the documented use of expendable items during trial implementation documented in the patient's diary. | — |
Countries
Germany
Contacts
Public ContactKai J. Lorenz
HNO-Abteilung, Bundeswehrkrankenhaus Ulm
Outcome results
None listed