View Clinical Trial (Medical Research Study)
Validity of a New Stroke Dysphagia Screening Tool
| City: |
|
Providence |
| State: |
|
Rhode Island |
| Zip Code: |
|
02903 |
| Conditions: |
|
Stroke |
| Purpose: |
|
Dysphagia or swallowing difficulty is common after stroke occurring in 25-78% of stroke
survivors depending on the anatomic location of the stroke and the diagnostic test used.
There are no universally accepted methods for doing a screen test at the bedside in the
immediate setting after stroke. This study will assess the reliability of a bedside screen
in terms of reproducibility of results between 2 independent screeners and in comparison to
a fiberoptic study done by a speech language pathologist.
|
| Study Summary: |
|
Specific Aims:
1. To show that the dysphagia screening tool achieves greater than 90% positive and
negative predictive values relative to the gold standard for dysphagia defined in this
study as the Fiberoptic Endoscopic Evaluation of Swallowing (FEES) as performed by
speech-language pathologists.
2. To show that the risk of aspiration pneumonia is less than 10% during hospitalization
in patients undergoing the dysphagia screening tool.
3. To show that the dysphagia screening tool is applicable across the spectrum of stroke
severity, as defined by the NIH stroke scale score.
4. To assess specific components and combinations of components of the dysphagia
screening tool with respect to positive and negative predictive values.
5. To show that the dysphagia screening tool has excellent inter-rater reliability and can
be performed in under 5 minutes.
Methods: The investigators will recruit 18 patients with a clinical diagnosis of acute
ischemic stroke. Patients with a clinical diagnosis of stroke will initially be screened
with the dysphagia screening tool within 24 hours of last known well admission by two
separate evaluators performed no more than 2 hours apart. The first evaluator will be
either a nurse (e.g. emergency medicine nurse) or physician (e.g. neurology resident)
certified in use of the screen. The second evaluator will be the nurse research coordinator
for the study. The first screen is part of routine clinical care and will be used to
determine the patient's eating status (NPO or full diet). Timing between evaluations will
be recorded. Patients will include those with an NIHSS of 8-16 inclusive. Patients with
primary intracerebral hemorrhage and those who are unable to read the consent form due to
language barrier (not aphasia) will be excluded from this study. Consent for aphasic
patients will be obtained from an authorized representative. Lesion side (right, left),
lesion location (hemispheric, brainstem, cerebellar), and TOAST classification (a validated
method of stroke mechanism classification) will be recorded. The results of patients who
are initially enrolled in the study but later excluded because of brain imaging findings
will be recorded. Patients who are studied by FEES within 6 hours of the first bedside
screen by ASHA certified speech-language pathologists will be included. Time from screening
to FEES examination will be recorded. A patient studied more than 6 hours after the first
bedside screen will be excluded. Patients who passed the initial screen but later failed
FEES examination will be made NPO because of the potential implications for clinical
outcome. Patients who fail the initial screen but who later pass the FEES examination wil
be released from NPO status. Results of brain imaging will also be recorded. Patients with
negative brain imaging will also be included because diagnostic imaging with CT may not be
sensitive in the first 24 hours and MRI may not be available within hours of arrival.
Patients included in the study will also be followed during their hospitalization for
clinical evidence of aspiration pneumonia up to 7 days. A 90-day phone call will be made to
determine the patient's level of function according to the modified Rankin scale, a standard
outcome tool for stroke. Patients whose final diagnosis is not stroke will be excluded from
analysis.
Statistical analysis:
Inter-rater reliability between bedside screeners will be calculated. Results of the screen
performed by the last bedside screener will be compared to findings on FEES. Sensitivity,
specificity, positive predictive value, and negative predictive value scores will be
calculated using 2 by 2 table analysis. Likelihood ratios will be calculated. Aspiration
pneumonia rates will be described with descriptive statistics.
|
| Criteria: |
|
Inclusion Criteria:
- Clinical diagnosis of ischemic stroke
- Age 18 years or older
- NIHSS 8-16
- Within 24 hours of last known well
Exclusion Criteria:
- Diagnosis of intracerebral hemorrhage, TIA, or other non-ischemic stroke diagnosis
- Patient or authorized representative unable to read consent form
|
| NCT ID: |
|
NCT01529723 |
| Primary Contact: |
|
Principal Investigator
Brian Silver, MD
Rhode Island Hospital
Brian Silver, MD
Phone: 401-444-8806
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Providence, Rhode Island 02903
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 23, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|