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Clinical Trials/DRKS00031268
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.

Registry
who.int
Start Date
February 27, 2023
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
MED-EL Elektromedizinische Geräte GmbH

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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