Stroke Circulatory System
Conditions
Interventions
This is a single-arm, preliminary, prospective, feasibility study of patients less than 72 h post-stroke, over a 31-day period in a hyperacute stroke unit: the Royal Victoria Infirmary, Newcastle-upon
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Are admitted to the Royal Victoria Infirmary Hyper-Acute Stroke Unit (HASU) with a suspected or confirmed diagnosis of a new stroke 2. Are sufficiently alert to tolerate clinical swallow examination or cough reflex testing (i.e. able to maintain alertness for at least 20 minutes) 3. Have adequate head control and are able to tolerate being positioned upright for the duration of the assessment Also: 4. Due to service restrictions, patients are required to have their swallowing assessment during working hours of Speech and Language Therapists carrying out cough reflex testing 5. Patients who are known to have high intracranial pressure will be discussed with the treating consultant prior to assessment as this is a potential contraindication for performing the test as per the protocol described by Miles and colleagues (2013) 6. Participants must have English as their primary language 7. Consent will be obtained prior to the assessment or the assessment will be completed in the participant's best interests if they are unable to consent (informed consent obtained)
Exclusion criteria
Exclusion criteria: 1. Are under 18 years of age 2. Are medically deteriorating or being treated palliatively 3. Are too agitated to engage in assessment 4. Have a history of previous silent aspiration identified on instrumental swallow assessment 5. Are unable to provide informed consent to participate in the study and do not have an appropriate spokesperson to provide consent on their behalf 6. Have a structural anomaly that could interfere with swallowing 7. Are more than 3 days post-stroke 8. COVID-19 suspected or confirmed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following variables will be assessed at one timepoint within 3 days of the onset of their stroke symptoms: 1. Observation of patients eating and drinking measured using the clinical swallowing examination (CSE) 2. Sensory and motor response of cough measured using cough reflex test (CRT) 3. Evaluation of swallowing measured using a fibreoptic endoscopic evaluation (FEES) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of eligible patients in this setting measured using the record of patients in the hyperacute stroke unit on each day of recruitment 2. Percentage of those eligible who consented to participate measured using patient study records at one timepoint 3. Demographics of eligible patients measured using patient study records at one timepoint 4. Duration of each test (CSE, CRT, FEES) measured using patient study records at one timepoint 5. Acceptability of FEES and CRT measured using a Likert scale) at one timepoint 6. Prevalence of silent aspiration by index tests (CSE, CRT) and the gold standard (FEES) measured using patient records; true and false positives, true and false negatives are recorded. Subsequently, statistics for diagnostic value are used to evaluate: sensitivity, specificity, positive and negative predictive values. These inform a preliminary assessment of likely diagnostic value and a power calculation for a larger study. 7. Power calculation predicated on diagnostic accuracy (overall agreement with gold standard test). McNemar’s Z-test was used to assess paired proportions; sample sizes were calculated using G-Power v3.1. measured from study results at one timepoint | — |
Countries
England, United Kingdom
Contacts
Public ContactJulie Trimble
Outcome results
None listed