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PES to Avoid Extubation Failure in Intubated Stroke Patients at High Risk of Severe Dysphagia

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ClinicalTrials.gov Identifier: NCT04010617
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Muenster

Brief Summary:

Post-extubation dysphagia (PED) recently became a growing concern as a major risk factor for extubation failure and significant contributor to poor patient outcomes with prevalence rates ranging from 12% to 69%, being highest in neurological patients (93%).

Pharyngeal electrical stimulation (PES) has been shown to improve airway safety and swallowing function tracheostomized stroke patients, thereby enhancing decannulation in this patient cohort.

In the present study the investigators evaluate whether PES is safe, feasible and effective in orotracheal intubated stroke patients at high risk of extubation failure.


Condition or disease Intervention/treatment Phase
Stroke Dysphagia Extubation Failure Device: Pharyngeal Electrical Stimulation (PES) Not Applicable

Detailed Description:

Endotracheal intubation and mechanical ventilation are common procedures for critically ill stroke patients. Although necessary and life-saving, timely extubation after ventilator weaning is desirable, because patients with delayed extubation experience higher pneumonia rate, increased need for tracheostomy, longer length of stay on the intensive care unit and higher mortality. On the other hand, extubation failure (EF) and subsequent need for emergent re-intubation is associated with similar sequelae.

Post-extubation dysphagia (PED) became a growing concern as a major risk factor for EF and significant contributor to poor patient outcomes with prevalence rates ranging from 12% to 69%, being highest in neurological patients (93%). Damage to the central swallowing network itself is the primary cause of PED in cerebrovascular disease, which constitutes the leading diagnosis on neuro-ICUs. Further mechanisms include pharyngolaryngeal lesions caused by the tube, critical illness neuropathy and myopathy leading to muscle weakness and dyscoordination of breathing and swallowing, and an impaired sensation due to sedation, mucosal damage, or the underlying critical illness itself. As a consequence reintubation rates in neurological collectives are as high as 20 to 40%.

Pharyngeal electrical stimulation (PES) has been shown to improve airway safety and swallowing function tracheostomized stroke patients, thereby enhancing decannulation in this patient cohort.

In the present study the investigators evaluate whether PES is safe, feasible and effective in orotracheal intubated stroke patients at high risk of extubation failure.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Observational trial with comparison to a historical control group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharyngeal Electrical Stimulation (PES) to Avoid Extubation Failure in Intubated Stroke at High Risk of Severe Dysphagia
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pharyngeal Electrical Stimulation
Orotracheal intubated patients at high risk of extubation failure will receive open-label PES
Device: Pharyngeal Electrical Stimulation (PES)
PES will be delivered by a commercial device (Phagenyx, Phagenesis Ltd, Manchester, UK), which comprises a nasogastric feeding catheter that houses stimulation ring-electrodes and a computerised base station that delivers stimulation in the range 1-50 mA at 5 Hz.




Primary Outcome Measures :
  1. Successful extubation [ Time Frame: 72 hours after extubation ]
    No re-intubation within 72 hours after extubation


Secondary Outcome Measures :
  1. Pneumonia [ Time Frame: up to 14 days ]
    Pneumonia post extubation until hospital discharge

  2. Feeding status [ Time Frame: up to 14 days ]
    Functional Oral Intake Scale

  3. Swallowing function [ Time Frame: 0-24 hours after extubation ]
    Fiberoptic Endoscopic Dysphagia Severity Scale

  4. Swallowing function [ Time Frame: 72-120 hours after extubation ]
    Fiberoptic Endoscopic Dysphagia Severity Scale

  5. Swallowing function [ Time Frame: up to 14 days ]
    Fiberoptic Endoscopic Dysphagia Severity Scale

  6. Length of stay of the ICU/intermediate care [ Time Frame: up to 60 days ]
    Length of stay in days

  7. Length of stay in hospital [ Time Frame: up to 120 days ]
    Length of stay in hospital in days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Acute stroke orotracheal intubation high-risk of extubation failure (DEFISS-score ≥4) successful respiratory weaning according to the treating intensivist within 24 to 72 hours

Exclusion Criteria:

Patients are excluded from study participation if any of the following apply:

  • Suffer from pre-existing neurogenic dysphagia or a condition that can cause dysphagia (for example Parkinson's Disease);
  • Suffer from non-neurogenic dysphagia (e.g. cancer);
  • Suffer from neuromuscular disorders (e.g. myasthenia gravis, motor neuron disease);
  • Participate in any other study potentially influencing the outcome of PES, both medicinal or medical device product related and for which the patient signed a consent form for his/her study participation;
  • Receive or have received within one month prior to the intended PES treatment any other type of standard cranial or percutaneous electrical stimulation therapy to treat dysphagia;
  • Have a pacemaker or an implantable defibrillator;
  • Have a nasal anatomical deformity, nasal airway obstruction, have had oesophageal surgery or any other circumstance where placement of a standard NG feeding tube would be deemed unsafe;
  • Have a cardiac or respiratory condition that might render the insertion of the catheter into the throat unsafe;
  • Are pregnant or nursing women;

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): NCT04010617


Contacts
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Contact: Rainer Dziewas, MD +49251834 ext 8239 dziewas@uni-muenster.de
Contact: Sonja Suntrup-Krueger, MD +49251834 ext 1127 sonja.suntrup-krueger@ukmuenster.de

Locations
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Germany
University Hospital Münster, Deparment of Neurology Recruiting
Münster, Germany, 48149
Contact: Rainer Dziewas, MD    +49251834 ext 8239    dziewas@uni-muenster.de   
Contact: Sonja Suntrup-Krueger, MD    +49251834 ext 1127    sonja.suntrup-krueger@ukmuenster.de   
Sponsors and Collaborators
University Hospital Muenster
Investigators
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Principal Investigator: Rainer Dziewas, MD Department of Neurology, University Hospital Münster, Germany

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Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT04010617     History of Changes
Other Study ID Numbers: 01072018
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: a subset of fully anonymised patient data may be available upon request from the authors

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Muenster:
Pharyngeal Electrical Stimulation
Stroke
Dysphagia
Re-intubation
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