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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470078
• Other study ID #: 2014-155
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: September 2018

Study information

• Verified date: February 2020
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Stroke

Intervention

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 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.

Locations

Country	Name	City	State
Germany	Department of Neurology, University of Muenster	Muenster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reintubation rate	Need for reintubation within 120 hours from extubation	120 hours
Primary	Pneumonia rate	Incidence of aspiration pneumonia within 120 hours from extubation	120 hours
Secondary	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
Secondary	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
Secondary	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.
Secondary	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