Z93.0 Z90.0
Conditions
Interventions
Group 1: The day after laryngectomy the patients will be supplied with HME-Filters, which will be used until discharge from hospital. The filter will be changed by the patient regularly.
The filters
Sponsors
Atos Medical GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - patient following complete laryngectomy immediately after surgery - age >= 18 years - written informed consent
Exclusion criteria
Exclusion criteria: - 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) - lacking compliance - participation in other interventional trials - physical, mental or other inability to supply required information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint of the clinical trial is the bronchial mucus production as measured by the number of tracheobronchial aspirations documented on the patient's diary over the course of the first ten post operative days. | — |
Secondary
| Measure | Time frame |
|---|---|
| cough frequency, determined from the patients's diary over the course of the first ten post operative days || bronchial mucus production, determined from the patients's diary over the course of the first ten post operative days || lung function at day 3 and 10 post surgery. 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 || direct costs of treatment, determined from a questionnaire (part of the CRF) over the course of the first ten post operative days || therapy compliance of the patient, the use of HME-filters as well as of other filter systems will be recorded in the CRF over the course of the ten first post operative days. || patient's satisfaction, determined from the patients's diary over the course of the first ten post operative days | — |
Countries
Germany
Contacts
Public ContactKai J. Lorenz
Bundeswehrkrankenhaus Ulm, HNO-Abteilung
Outcome results
None listed