Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharyngeal Electrical Stimulation | Experimental | Orotracheal intubated patients at high risk of extubation failure will receive open-label PES |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharyngeal Electrical Stimulation (PES) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful extubation | No re-intubation within 72 hours after extubation | 72 hours after extubation |
| 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 |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rainer Dziewas, MD | Contact | +49251834 | 8239 | dziewas@uni-muenster.de |
| Sonja Suntrup-Krueger, MD | Contact | +49251834 | 1127 | sonja.suntrup-krueger@ukmuenster.de |
| Name | Affiliation | Role |
|---|---|---|
| Rainer Dziewas, MD | Department of Neurology, University Hospital Münster, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Münster, Deparment of Neurology | Recruiting | Münster | 48149 | Germany |
a subset of fully anonymised patient data may be available upon request from the authors
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Observational trial with comparison to a historical control group
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |