DRKS00031268
Recruiting
未知
Exploring the effects of surface electrostimulation to improve swallow function in dysphagic patients
MED-EL Elektromedizinische Geräte GmbH0 sites40 target enrollmentFebruary 27, 2023
ConditionsR13.9
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- R13.9
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \= 18 \= 75 years
- •Patients suffering from dysphagia following a minimum of 24h intubation, showing a PAS grade \= 3 and/or Yale\-Scale score \=3 (Valleculae and/or S.Piriformis)
- •Patients anatomically, mentally, and psychologically compatible with the criteria for participation in this clinical investigation
- •Patients routinely hospitalized for the entire duration of stimulation (i.e., two weeks)
- •Highly motivated patients with realistic expectations regarding their participation in this clinical investigation
- •Signed and dated informed consent before the start of any clinical investigationspecific procedure for all the recruited subjects (with special rule for patients prevented from writing)
Exclusion Criteria
- •Lack of compliance with any inclusion criteria
- •Pregnant or breast\-feeding women
- •Diagnosed neurologic or non\-neurologic diseases that would affect the dysphagia
- •symptoms caused by intubation, e.g., apoplex, oropharyngeal dysphagia or diagnosed
- •oropharyngeal injuries or other impairments
- •Current obtunded levels of alertness
- •Significant agitation
- •Infections, inflammatory processes, or any other conditions or injuries that interest the
- •external neck region and the throat
- •Other clinical conditions that could affect the results of this clinical investigation, e.g.,
Outcomes
Primary Outcomes
Not specified
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