A Single-centre, Double Blind, Randomised Controlled Clinical Trial to Evaluate the Effect of Electrical Pharyngeal Stimulation as a Treatment for Stroke-related Dysphagia in Tracheostomized Stroke Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- University Hospital Muenster
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Readiness for decannulation
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to evaluate whether electrical pharyngeal stimulation in addition to standard care can enhance short-term swallow recovery in tracheostomized dysphagic stroke patients and thereby facilitate earlier decannulation compared to sham treatment plus standard care.
Detailed Description
Readiness for decannulation is assessed after three days of either real or sham electrical pharyngeal stimulation. In case a patient cannot be decannulated at that time point, there is an open-label follow-up treatment phase, in which every patient in the sham treatment arm gets another three days of real electrical pharyngeal stimulation to not deprive any patient of a potentially beneficial treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •severe dysphagia due to acute stroke
- •completely weaned from mechanical ventilation
- •impossibility of decannulation because of severe dysphagia with ongoing aspiration
Exclusion Criteria
- •preexisting dysphagia
- •comorbidities that can possibly cause dysphagia
- •psychiatric comorbidities
- •pacemaker or other implanted electronic devices
Outcomes
Primary Outcomes
Readiness for decannulation
Time Frame: 3 days
Difference in readiness for decannulation as assessed by a standardized fiberoptic endoscopic evaluation protocol after three days of treatment between real and sham treatment groups
Secondary Outcomes
- Functional Oral Intake Scale (FOIS) at discharge(until discharge)
- length of stay on ICU / in the hospital and time from stimulation to discharge(until discharge)
- modified Rankin Scale (mRS) at discharge(until discharge)