Neurogenic dysphagia Signs and Symptoms
Conditions
Interventions
We are conducting a post-market-release observational study of our device. All treatments delivered in this study are considered standard practice.
The Phagenyx treatment is given thr
Sponsors
Phagenesis Limited (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible for study participation if they: 1. Are suspected to have oropharyngeal dysphagia with a Dysphagia Severity Ratings Scale (DSRS) score of 6 or higher 2. When eating independency would be jeopardised by partial or total paralysation of upper extremities and have a Functional Oral Intake Scale (FOIS) score equal to or lower than 5 3. When no oral food intake is possible and DSRS score is 12 and FOIS-score is 1 and have a Penetration-Aspiration Score (PAS) of 4 or higher 4. Have a well identified dysphagia causing neurological event such as, but not limited to, stroke or brain injury, potentially but not necessarily leading to the need of long-term mechanical ventilation or a tracheostomy 5. Are over 18 years old 6. Give themselves or have legal relatives/authorities representing themselves to give voluntary written informed consent
Exclusion criteria
Exclusion criteria: 1. Have an undefined date of medical event causing the dysphagia 2. Suffer from non-neurogenic dysphagia (e.g. cancer) 3. Participate in any other study potentially influencing the outcome of the Phagenyx treatment, both medicinal or medical device product related 4. Receive or have received within one month prior to the intended Phagenyx treatment any other type of standard cranial or percutaneous electrical stimulation therapy to treat dysphagia 5. Have a cardiac pacemaker or a cardioverter defibrillator implanted unless the device can be switched off completely at the time of treatment delivery 6. Have experienced an oesophageal perforation, or have an oesophageal stricture or pouch; 7. Have an unstable cardiopulmonary status 8. Receive continuous oxygen treatment or have the equipment for such treatment permanently in place preventing the positioning of the Phagenyx Catheter (this does not exclude patients who are intubated or have a tracheostomy where 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 that can have the oxygen treatment temporarily stopped and equipment removed during Phagenyx treatment) 9. Are pregnant or nursing women 10. Require emergency treatment, preventing appropriate conduct of the subject informed consent process 11. Have a life expectancy less than the duration of the patient?s follow up period, i.e. less than three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is assessed by means of two standard functional scoring systems and one instrumental scoring system: 1. DSRS: Dysphagia Severity Rating Scale 2. FOIS: Functional Oral Intake Scale 3. PAS: Penetration Aspiration Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are assessed by means of the following clinical data at one or more time points: baseline, at time intervals of 24-72 hrs, at pre-hospital discharge and at three months 1. Demographics described in terms of weight, age, sex, BMI, and assessment of distance between nostrils of the nose and the pharynx based on some external facial anatomical measures 2. Recording of the symptoms and underlying causes of dysphagia in treated patients 3. Assessment of the severity of swallowing using the Eating Assessment Tool (EAT-10) score 4. Assessment of the severity of secretion (Murray scale) 5. Measurement of the time and number of attempts to insert the stimulation catheter 6. Assessment of the ease of catheter positioning 7. Recording of subjective and personal appreciation of Phagenyx treatment prior and at the end of the study 8. Recording of the different Speech and Language Therapist-therapies in addition to the management plan at baseline 9. Measurement of the time period between Phagenyx treatment delivery and the dysphagia causal event 10. The outcome of DSRS and other standard scores related to the time of the day Phagenyx treatment is first delivered 11. Recording of the treatment optimisation parameters prior to every treatment delivery 12. Assessment of feeding status by means of the FOIS-score and the PEG-status 13. Recording of the type, purpose and duration of artificial ventilation 14. Recording of the timing of extubation or decannulation (in tracheostomy patients) 15. Assessment of the patient?s QoL using multiple questionnaires, such as the Barthel Index, the EURO-Qol-5D prior, and the Dysphagia Handicap Index 16. Recording of any device related Adverse Events and de | — |
Countries
Austria, Germany, United Kingdom
Outcome results
None listed