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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

Tracking Information
First Submitted Date  ICMJE May 29, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date July 8, 2019
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
Successful extubation [ Time Frame: 72 hours after extubation ]
No re-intubation within 72 hours after extubation
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
  • Pneumonia [ Time Frame: up to 14 days ]
    Pneumonia post extubation until hospital discharge
  • Feeding status [ Time Frame: up to 14 days ]
    Functional Oral Intake Scale
  • Swallowing function [ Time Frame: 0-24 hours after extubation ]
    Fiberoptic Endoscopic Dysphagia Severity Scale
  • Swallowing function [ Time Frame: 72-120 hours after extubation ]
    Fiberoptic Endoscopic Dysphagia Severity Scale
  • Swallowing function [ Time Frame: up to 14 days ]
    Fiberoptic Endoscopic Dysphagia Severity Scale
  • Length of stay of the ICU/intermediate care [ Time Frame: up to 60 days ]
    Length of stay in days
  • Length of stay in hospital [ Time Frame: up to 120 days ]
    Length of stay in hospital in days
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PES to Avoid Extubation Failure in Intubated Stroke Patients at High Risk of Severe Dysphagia
Official Title  ICMJE Pharyngeal Electrical Stimulation (PES) to Avoid Extubation Failure in Intubated Stroke at High Risk of Severe Dysphagia
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Observational trial with comparison to a historical control group
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Dysphagia
  • Extubation Failure
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Pharyngeal Electrical Stimulation
Orotracheal intubated patients at high risk of extubation failure will receive open-label PES
Intervention: Device: Pharyngeal Electrical Stimulation (PES)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 4, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rainer Dziewas, MD +49251834 ext 8239 dziewas@uni-muenster.de
Contact: Sonja Suntrup-Krueger, MD +49251834 ext 1127 sonja.suntrup-krueger@ukmuenster.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04010617
Other Study ID Numbers  ICMJE 01072018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: a subset of fully anonymised patient data may be available upon request from the authors
Responsible Party University Hospital Muenster
Study Sponsor  ICMJE University Hospital Muenster
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rainer Dziewas, MD Department of Neurology, University Hospital Münster, Germany
PRS Account University Hospital Muenster
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP