Dysphagia, Stroke
Conditions
Keywords
extubation
Brief summary
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.
Interventions
DEVICEPhagenyx-Catheter, Phagenesis Limited, UK.
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.
DEVICESham stimulation
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.
Sponsors
University Hospital Muenster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reintubation rate | 120 hours | Need for reintubation within 120 hours from extubation |
| Pneumonia rate | 120 hours | Incidence of aspiration pneumonia within 120 hours from extubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | Participants will be followed for the duration of stay on the intensive care unit, an expected average of 3 weeks | Length of stay on the intensive care unit |
| Time until oral nutrition | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Time span from extubation until consumption of an completely oral diet is safely possible |
| PEG tube placement | Participants will be followed for the duration of hospital stay, an expected average of 5 weeks. | Number of participants needing percutaneous endogastric tube placement due to persistent severe dysphagia |
| Swallowing function | after 3 days of treatment | 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 |
Countries
Germany
Outcome results
None listed