Skip to main content
OpenTrials
Completed

NCT Number: NCT02470078

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, University of Muenster

Münster, 48129, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 stimulation

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 12, 2015
Registry last updated
Feb 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.