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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pharyngeal Electrical Stimulation (PES) to Avoid Extubation Failure in Intubated Stroke at High Risk of Severe Dysphagia

Conditions
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Stroke, Dysphagia, Extubation Failure

Intervention / Treatment
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* Device: Pharyngeal Electrical Stimulation (PES)


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Observational trial with comparison to a historical control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharyngeal Electrical Stimulation<br>Orotracheal intubated patients at high risk of extubation failure will receive open-label PES | Device: Pharyngeal Electrical Stimulation (PES)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful extubation | No re-intubation within 72 hours after extubation | 72 hours after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumonia | Pneumonia post extubation until hospital discharge | up to 14 days | 
| Feeding status | Functional Oral Intake Scale | up to 14 days | 
| Swallowing function | Fiberoptic Endoscopic Dysphagia Severity Scale | 0-24 hours after extubation | 
| Swallowing function | Fiberoptic Endoscopic Dysphagia Severity Scale | 72-120 hours after extubation | 
| Swallowing function | Fiberoptic Endoscopic Dysphagia Severity Scale | up to 14 days | 
| Length of stay of the ICU/intermediate care | Length of stay in days | up to 60 days | 
| Length of stay in hospital | Length of stay in hospital in days | up to 120 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharyngeal Electrical Stimulation, Stroke, Dysphagia, Re-intubation