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

University Hospital Muenster60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Stroke Dysphagia

Interventions

Phagenyx-Catheter, Phagenesis Limited, UK.DEVICE

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 stimulationDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Neurology, University of Muenster

Münster, Germany

Outcomes

Primary Outcomes

Reintubation rate

Need for reintubation within 120 hours from extubation

Time frame: 120 hours

Pneumonia rate

Incidence of aspiration pneumonia within 120 hours from extubation

Time frame: 120 hours

Secondary Outcomes

Length of stay

Length of stay on the intensive care unit

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: after 3 days of treatment

Data from ClinicalTrials.gov

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