Multicentre trial on immediate rehabilitation using HME-filters after a total laryngectomy

Not Applicable

• Conditions: Z93.0; Z90.0; Tracheostomy status; Acquired absence of part of head and neck

• Registration Number: DRKS00000379
• Lead Sponsor: Atos Medical GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-24
• Study Completion: 2012-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

patient following complete laryngectomy immediately after surgery
- age >= 18 years
- written informed consent

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.<br><br>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