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

Primary Purpose

Stroke, Dysphagia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Phagenyx-Catheter, Phagenesis Limited, UK.
Sham stimulation
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring extubation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neurology, University of Muenster

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Pharyngeal electrical stimulation

Sham stimulation

Arm Description

Pharyngeal electrical stimulation once daily for 10 minutes on three consecutive days.

Sham stimulation once daily for 10 minutes on three consecutive days.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of stay
Length of stay on the intensive care unit
Time until oral nutrition
Time span from extubation until consumption of an completely oral diet is safely possible
PEG tube placement
Number of participants needing percutaneous endogastric tube placement due to persistent severe dysphagia
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

Full Information

First Posted
June 3, 2015
Last Updated
February 5, 2020
Sponsor
University Hospital Muenster
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1. Study Identification

Unique Protocol Identification Number
NCT02470078
Brief Title
Pharyngeal Electrical Stimulation for the Treatment of Post-extubation Dysphagia in Acute Stroke
Official Title
Randomised Controlled Trial of Pharyngeal Electrical Stimulation for the Treatment of Post-extubation Dysphagia in Acute Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Muenster

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Dysphagia
Keywords
extubation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pharyngeal electrical stimulation
Arm Type
Experimental
Arm Description
Pharyngeal electrical stimulation once daily for 10 minutes on three consecutive days.
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
Sham stimulation once daily for 10 minutes on three consecutive days.
Intervention Type
Device
Intervention Name(s)
Phagenyx-Catheter, Phagenesis Limited, UK.
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reintubation rate
Description
Need for reintubation within 120 hours from extubation
Time Frame
120 hours
Title
Pneumonia rate
Description
Incidence of aspiration pneumonia within 120 hours from extubation
Time Frame
120 hours
Secondary Outcome Measure Information:
Title
Length of stay
Description
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
Title
Time until oral nutrition
Description
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
Title
PEG tube placement
Description
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.
Title
Swallowing function
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer Dziewas, MD
Organizational Affiliation
University Hospital Münster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, University of Muenster
City
Muenster
ZIP/Postal Code
48129
Country
Germany

12. IPD Sharing Statement

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

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