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

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ClinicalTrials.gov Identifier: NCT02470078
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stroke Dysphagia Device: Phagenyx-Catheter, Phagenesis Limited, UK. Device: Sham stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Reintubation rate [ Time Frame: 120 hours ]
    Need for reintubation within 120 hours from extubation

  2. Pneumonia rate [ Time Frame: 120 hours ]
    Incidence of aspiration pneumonia within 120 hours from extubation


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470078


Locations
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Germany
Department of Neurology, University of Muenster
Muenster, Germany, 48129
Sponsors and Collaborators
University Hospital Muenster
Investigators
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Principal Investigator: Rainer Dziewas, MD University Hospital Münster
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Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT02470078    
Other Study ID Numbers: 2014-155
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Keywords provided by University Hospital Muenster:
extubation
Additional relevant MeSH terms:
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Deglutition Disorders
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases