Study comparing long-term measurement of swallowing with endoscopic swallowing examination in the context of tracheostomy tube management in patients with dysphagia.
Phase 4
- Conditions
- R13.1
- Registration Number
- DRKS00016952
- Lead Sponsor
- Klinik für Hals- Nasen-, Ohren- Krankheiten Unfallkrankenhaus Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 103
Inclusion Criteria
Healthy patients as comparison group; patients with a swallowing disorder (diagnosis confirmation and severity assessment), patients with a tracheal cannula due to a swallowing disorder.
Exclusion Criteria
Children, Pregnancy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prior to endoscopic swallowing examination (FEES) with the purpose of tracheal tube status change, a 2-4h long-term measurement is performed. The determined parameters (swallowing frequency, extension and speed of laryngeal elevation, swallowing duration, breathing) are compared with the decision for tracheal cannula status change and thus the measurement procedures are tested for correlation.
- Secondary Outcome Measures
Name Time Method Healthy persons readings are setting the basis for the calculation of the percentiles for individual parameters.<br>Patients with a positive decision for a tracheal tube status-change, will afterwards participate in a 1h long-term measurement to evaluate the result.<br>By means of a chest strap, respiration will be recorded and breath-swallow patterns will be identified and analyzed. <br>Strongly influencing criteria for a safe tracheal cannula management will be identified and evaluated. <br>Furthermore, algorithms for swallow assessment will be developed to simplify decision making in clinical practice and thus improve the quality of life of patients.