Pharyngeal Electrical Stimulation for the Treatment of Post-extubation Dysphagia in Acute Stroke

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether pharyngeal electrical stimulation in addition to standard care can enhance swallowing recovery in severely dysphagic stroke patients post extubation compared to sham treatment plus standard care.

Official Title
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Randomised Controlled Trial of Pharyngeal Electrical Stimulation for the Treatment of Post-extubation Dysphagia in Acute Stroke Patients

Conditions
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Stroke, Dysphagia

Intervention / Treatment
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* Device: Phagenyx-Catheter, Phagenesis Limited, UK.
* Device: Sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - severe dysphagia post extubation due to acute stroke Exclusion Criteria: preexisting dysphagia comorbidities that can possibly cause dysphagia psychiatric comorbidities pacemaker or other implanted electronic devices

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharyngeal electrical stimulation<br>Pharyngeal electrical stimulation once daily for 10 minutes on three consecutive days. | Device: Phagenyx-Catheter, Phagenesis Limited, UK.<br>* Pharyngeal electrical stimulation via an intraluminal catheter (Phagenesis Ltd.) once daily for 10 minutes on three consecutive days. The intensity of the electrical stimulation is determined following the calculation of suitable sensory threshold, tailored to the individual patients. After determining the optimal stimulation intensity, 10 minutes of stimulation are delivered.<br>|
| Sham Comparator: Sham stimulation<br>Sham stimulation once daily for 10 minutes on three consecutive days. | Device: Sham stimulation<br>* The intraluminal catheter (Phagenesis Ltd.) for pharyngeal electrical stimulation is placed. In the sham group the optimisation procedure was imitated as closely as possible to mitigate any bias or effect of time spent interacting with the patient during PES, but no current was applied. After this procedure 10 min of sham stimulation were delivered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reintubation rate | Need for reintubation within 120 hours from extubation | 120 hours | 
| Pneumonia rate | Incidence of aspiration pneumonia within 120 hours from extubation | 120 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Length of stay on the intensive care unit | Participants will be followed for the duration of stay on the intensive care unit, an expected average of 3 weeks | 
| Time until oral nutrition | Time span from extubation until consumption of an completely oral diet is safely possible | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 
| PEG tube placement | Number of participants needing percutaneous endogastric tube placement due to persistent severe dysphagia | Participants will be followed for the duration of hospital stay, an expected average of 5 weeks. | 
| Swallowing function | Salient semiquantitative parameters of swallowing function (leaking, penetration, aspiration, residues, delayed triggering of swallow reflex) as assessed by a standardized fiberoptic endoscopic evaluation protocol after three days of treatment | after 3 days of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extubation