Dysphagia
Conditions
Interventions
Duration of intervention: 1-10 days
Intervention: thin iodine liquid as control versus iodine liquid thickened with a gum based thickener to different viscosity levels. Each variety will be given as
Sponsors
Nutricia Research BV
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of stroke, and minimum 28 days since stroke 2. Clinical signs or symptoms of swallowing dysfunction, based on Eating Assessment Tool (EAT-10) questionnaire, or bedside clinical test or water swallow test, or referral by medical doctor for Video FluoroScopy (VFS)-test, or current use of thickened products 3. No alterations in consciousness (score of 0 or 1 in the first question of NIH Stroke Scale (NIHSS)) 4. Age ≥ 18y 5. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with respiratory insufficiency in need of additional oxygen 2. Dysphagia not related to stroke 3. History of progressive neurological disorders (e.g. Parkinson’s disease, MS) 4. Tumour or radiotherapy of the head and neck region 5. Unstable medical conditions that may interfere with VFS 6. Patients with swallowing dysfunction caused by xerostomia induced by drugs 7. Prior medical history or conditions (like tracheostomy tube) that would put the patient at risk of pre-existing swallow disorder 8. Severe cognitive disorders or Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements and instructions 9. Not able to undergo VFS due to incapability of sitting posture 10. Known pregnancy and/or lactating 11. Participation in any other studies involving investigational or marketed products within four weeks prior to start of the study 12. Allergy to any ingredient of test product or iodine products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects that swallow viscosity levels 1, 2 and 3 safely (PAS score 1,2) compared to thin iodine liquid control | — |
Secondary
| Measure | Time frame |
|---|---|
| • Safety of swallowing per individual viscosity as measured by: • Percentage of subjects that swallow safely (PAS score 1,2) • Percentage of subjects with penetration (PAS score 3,4,5) • Percentage of subjects with aspiration (PAS score 6,7,8) • Mean PAS score • Efficacy of swallowing per individual viscosity as expressed by: • Presence and severity of oral residue (score 0,1,2) Presence and severity of pharyngeal residue (score 0,1,2) | — |
Contacts
Public ContactMirjam Slagter
Uppsalalaan 12, 3584 CT Utrecht
Outcome results
None listed