Patients after supratentorial stroke with neurogenic dysphagia who need mechanical ventilation support initially but are weaned from this support and who are tracheotomised thereafter to reduce potential complications, but the tracheal tube cannot be removed due to ongoing swallowing problems and risks for penetration and aspiration of saliva Nervous System Diseases Neurogenic dysphagia
Conditions
Interventions
1. CE-marked Phagenyx Base Station (EPS1) and Phagenyx catheter are commercially available for the treatment of neurogenic dysphagia and apply a standard electrical stimulation treatment at 5 Hz via t
Sponsors
Phagenesis Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Haemorrhagic or ischaemic stroke 2. Supratentorial 3. Mechanically ventilated for a minimum of 48 hours after the stroke event 4. Tracheotomised for any reason 5. Weaned from mechanical ventilation 6. Not taking sedatives for a minimum of 3 days 7. Ineligible for decannulation for a minimum of 10 days after the stroke event 8. Ineligible for decannulation for a minimum of 24 hours and a maximum of 72 hours after the first decannulation assessment 9. Cannot receive oral food (DSRS=12 and FOIS = 1) 10. Richmond Agitation and Sedation Scale > – 1 11. > 18 years old 12. Voluntary written informed consent provided by patients or their legal relatives/authorities
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 27/07/2015: 1. Undefined date of stroke causing the dysphagia (but not excluded stroke occurring during the night, for which the date will be the morning the stroke was observed) 2. Pre-existing dysphagia 3. Infratentorial stroke 4. Pre-existing neurogenic dysphagia or a disease linked to this symptom (e.g., Parkinson disorder) 5. Non-neurogenic dysphagia (e.g., cancer) 6. Neuromuscular disorders (e.g., myasthenia gravis or motor neurone disease) 7. Participating in any other study (of a medicine or medical device) that might affect the outcome of PES, and for which the patient signed a consent form 8. Receiving or have received within 1 month before the intended PES treatment any other type of standard cranial or percutaneous electrical stimulation therapy to treat dysphagia 9. Have a pacemaker or an implantable defibrillator 10. 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 11. Have a cardiac or respiratory condition that might render the insertion of the catheter into the throat unsafe 12. Receive oxygen therapy whilst the oxygen supply is in place or in operation 13. Pregnant or nursing women 14. Requiring emergency treatment that prevents the appropriate informed consent process 15. Life expectancy less than the duration of the patient’s follow-up (i.e., < 3 months) Previous exclusion criteria: 1. Undefined date of stroke causing the dysphagia (but not excluded stroke occurring during the night, for which the date will be the morning the stroke was observed) 2. Pre-existing dysphagia 3. Infratentorial stroke 4. Pre-existing neurogenic dysphagia or a disease linked to this symptom (e.g., Parkinson disorder) 5. Non-neurogenic dysphagia (e.g., cancer) 6. Neuromuscular disorders (e.g., myasthenia gravis or motor neurone disease) 7. Participating in any other study (of a medicine or medical device) that might affect the outcome of PES, and for which the patient signed a consent form 8. Receiving or have received within 1 month before the intended PES treatment any other type of standard cranial or percutaneous electrical stimulation therapy to treat dysphagia 9. Cardiac pacemaker or cardioverter defibrillator, unless device can be switched off completely at the time of treatment 10. Oesophageal perforation, oesophageal stricture or pouch 11. Unstable cardiopulmonary status 12. Severe pneumonia that cannot be stabilised by medication and prevents decannulation 13. Receiving continuous oxygen treatment or having equipment for such treatment permanently in place, preventing the positioning of the Phagenyx catheter (does not exclude patients who are intubated or have a tracheotomy in which an inflated balloon creates a firm barrier between the space where oxygen might be present (trachea/lungs) and the space where the electrical stimuli are delivered (oropharynx), or patients who can have the oxygen treatment temporarily stopped and equipment removed during PES treatment) 14. Pregnant or nursing women 15. Requiring emergency treatment that prevents the appropriate informed consent process 16. Life expectancy less than the duration of the patient’s follow-up (i.e., < 3 months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients in the early treatment group who can be decannulated* after the first exposure to standard PES treatment 2. Proportion of patients in the late treatment group who can be decannulated* at a similar timepoint without exposure to the standard PES treatment Decannulation success measured at 3-5 days post Day 0 (randomisation) with Warnecke et al. 2013 decannulation protocol. Added 27/07/2015: *Cuff deflation is considered as decannulation | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 10/11/2015: 1. Severity of dysphagia after PES treatment measured at Day 0 (randomisation), each decannulation attempt, every 48 hours for first 10 days, every 5 days after day 10 up to day 30 and at 3 months, measured with standard assessment scales (Dysphagia Severity Rating Scale [DSRS] and Functional Oral Intake Scale [FOIS]) and comparison with baseline 2. Success rates of decannulation in the late treatment group of the study after exposure to the standard PES treatment 3. Success rates of decannulation in the early treatment group of the study after a second exposure to the standard PES treatment 4. Treatment optimisation parameters (threshold, tolerance and intensity of the electrical stimulation) 5. Severity of the stroke measured using the standard NIHSS and modified Ranking Scale (mRS) at different time points after the PES treatment during the 30-day follow-up period and for mRS at the 3-month timepoint Previous secondary outcome measures: 1. Severity of dysphagia after PES treatment measured at Day 0 (randomisation), each decannulation attempt, every 48 hours for first 10 days, every 5 days after day 10 up to day 30 and at 3 months, measured with standard assessment scales (Dysphagia Severity Rating Scale [DSRS] and Functional Oral Intake Scale [FOIS]) and comparison with baseline 2. Success rates of decannulation in the late treatment group of the study after exposure to the standard PES treatment 3. Success rates of decannulation in the early treatment group of the study after a second exposure to the standard PES treatment 4. Treatment optimisation parameters (threshold, tolerance and intensity of the electrical stimulation) 5. Severity of the stroke, measured with the standard National Institutes of Health Stroke Scale and modified Ranking Scale at Day 0 (randomisation), day 10 and every 5 days up to days 30, and at 3 months | — |
Countries
Austria, Germany, Italy
Contacts
Public ContactSatish Mistry
Outcome results
None listed