Prospective randomized controlled study on the influence of closed vs open tracheostomy tubes on swallowing in patients with neurogenic dysphagia
Not Applicable
Recruiting
- Conditions
- R13.0
- Registration Number
- DRKS00003060
- Lead Sponsor
- Schoen Klinik Bad Ailbing
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
neurogenic dysphagia [clinical signs: modified Evan´s Blue Dye test (Belafsky et al., 2003); De-Pippo-water test (Suiter & Leder, 2008)]
- monohemispheric lesions
- patients will be included consecutively
- no previous neurologic or relevant anatomic morphologic lesions
- no peripheral (2nm MN) vocal cord paralysis
- effective reflectory cough
- trach tube can be uncuffed for 10 minutes without relevant SPO2 decrease
- no oropharyngeal tumors
-no previous surgery (aero-digestive tract)
Exclusion Criteria
- no written consent
- severe not substitutable coagulation deficits
- esophageal diverticulum
- respiratory insufficiency (SaO2<90%)
- bradycardia (<50/min)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Manometric pressure differences (between base of tongue and pharyngeal wall) during swallowing <br>method: pharyngeal manometry<br>measurement points: oropharynx, hypopharynx, upper esophageal sphincter<br>data points: maximal pressure, duration of pressure<br>
- Secondary Outcome Measures
Name Time Method degrees of aspiration (Penetration-Aspiration Scale, Rosenbek et al., 1996);<br>data extraction: simultaneous manometric and endoscopic measurement during swallowing (puree)