R13.9
Conditions
Interventions
Group 1: Arm L: logopedic session
The hospitalized subjects will solely undergo logopedic treatment according to the routine protocol of the site (once per day from Monday to Friday). Prior to each Mo
Sponsors
MED-EL Elektromedizinische Geräte GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion 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
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., respiration issues (decompensated asthma, decompensated COPD) or severe generalized muscle disease • Skin defects or wounds in the stimulation area • Current use of active implants • Current use of metal implants in the neck region • Endotracheally intubated patients • Known allergies or intolerance to the material used for this clinical investigation • Parallel participation in a device/drug clinical investigation in the period of data collection, which could confound the results of the clinical investigation 2021CIP005. • Anything that, in the opinion of the Principal Investigator, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this clinical investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Medical acts: • Demographics • Medical and medication history • Assessed condition history • Assessed condition treatment record • Logopedic sessions (behavioral dysphagia therapy): protocol, administration time, no. of session already performed at the time of enrolment - Reports created manually during the stimulation session: • Stimulation reports (including stimulation parameters) - Printed questionnaires (or scanned as PDF), which have been filled out manually: • Eating Assessment Tool (EAT-10) - Videos: • FEES (flexible endoscopic evaluation of swallowing) (used for the evaluation described below) - On the basis of the FEES investigation and/or videos assessed according to the following scores: • Secretion Severity Rating Scale (SSRS) • Penetration-Aspiration Scale • Aspiration severity scale • Yale Pharyngeal Residue Severity Rating Scale • FOIS-G | — |
Secondary
| Measure | Time frame |
|---|---|
| This clinical investigation has no secondary objectives. | — |
Countries
Austria
Contacts
Public ContactPia Plattner
MED-EL Elektromedizinische Geräte GmbH
Outcome results
None listed