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

Not Applicable

Completed

• Conditions: Dysphagia; Stroke
• Interventions: Device: Phagenyx-Catheter, Phagenesis Limited, UK.; Device: Sham stimulation

• Registration Number: NCT02470078
• Lead Sponsor: University Hospital Muenster

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-12
• Study Start: 2015-07
• Primary Completion: 2018-06
• Study Completion: 2018-09
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharyngeal electrical stimulation	Phagenyx-Catheter, Phagenesis Limited, UK.	Pharyngeal electrical stimulation once daily for 10 minutes on three consecutive days.
Sham stimulation	Sham stimulation	Sham stimulation once daily for 10 minutes on three consecutive days.

Primary Outcome Measures

Name	Time	Method
Pneumonia rate	120 hours	Incidence of aspiration pneumonia within 120 hours from extubation
Reintubation rate	120 hours	Need for reintubation within 120 hours from extubation

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Department of Neurology, University of Muenster; 🇩🇪 Muenster, Germany