Impact of continuous 'above cuff ventilation' on aspiration status in neurogenic dysphagia
- Conditions
- R13.1
- Registration Number
- DRKS00033639
- Lead Sponsor
- Helios Klinikum Krefeld GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 56
Patients with dysphagia and an inserted tracheostomy tube,
-Tracheostoma (surgical or dilative) with partially unblocked tracheostomy tube (min. 6 hours per day),
-Tracheal cannula with subglottic suction (Trachoe vario extract). The cannula must be approved for subglottic insufflation of compressed air (Trachoe vario extract: REF: 470, REF: 471 with CE approval),
- Feasibility of the FEES
-Written declaration of consent from the patient or their legal representative
-There are no contraindications for the use of Trachoe tracheostomy tubes with subglottic suction line
-Participation in other interventional examinations,
-tracheomalacia,
-Patients with fresh tracheostomy (less than 7 days after stoma creation)
-ENT tumor surgery or radiation in the throat area,
-Pre-existing oesophageal dysphagia (achalasia, motility disorder),
-Continuous ventilation,
-Obstruction of the upper airways
-Patients with surgically induced emphysema or infections of the tracheal tissue
-Pregnancy or breastfeeding,
-Persons who are in a dependent / employment relationship with the sponsor, supporter or investigator
-Placement in an institution due to a court or official order.
-Deep sedation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary parameters during FEES (pre-interventional/post-interventional): Secretion status (NZSS), swallowing safety (PAS), swallowing efficiency (Yale Residue Scale), pharyngeal sensitivity (touch technique)
- Secondary Outcome Measures
Name Time Method utritional status (FOIS-G), decannulation rate