Pharyngeal Electrical Stimulation for the Treatment of Post-extubation Dysphagia in Acute Stroke
|ClinicalTrials.gov Identifier: NCT02470078|
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : February 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stroke Dysphagia||Device: Phagenyx-Catheter, Phagenesis Limited, UK. Device: Sham stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomised Controlled Trial of Pharyngeal Electrical Stimulation for the Treatment of Post-extubation Dysphagia in Acute Stroke Patients|
|Actual Study Start Date :||July 2015|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||September 2018|
Experimental: Pharyngeal electrical stimulation
Pharyngeal electrical stimulation once daily for 10 minutes on three consecutive days.
Device: Phagenyx-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.
Sham Comparator: Sham stimulation
Sham stimulation once daily for 10 minutes on three consecutive days.
Device: Sham 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.
- Reintubation rate [ Time Frame: 120 hours ]Need for reintubation within 120 hours from extubation
- Pneumonia rate [ Time Frame: 120 hours ]Incidence of aspiration pneumonia within 120 hours from extubation
- Length of stay [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470078
|Department of Neurology, University of Muenster|
|Muenster, Germany, 48129|
|Principal Investigator:||Rainer Dziewas, MD||University Hospital Münster|