Clinical trial NCT00141752: Toronto Bedside Swallowing Screening Test (TOR-BSST) - A Bedside Swallowing Screening for Stroke Patients
Official title: Toronto Bedside Swallowing Screening Test (TOR-BSST) - A Bedside Swallowing Screening for Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrovascular Accident
Deglutition Disorders
Keywords: Cerebrovascular Accident
Deglutition Disorders
stroke
dysphagia
screening
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Stroke Network
name: Toronto Rehabilitation Institute
name: Parkwood Hospital, London, Ontario
name: Sunnybrook Health Sciences Centre
name: Hamilton Health Sciences Corporation
First posted: 2005-09-01
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly admitted patients with a diagnosis of stroke (refer to eligibility criteria)

Brief summary: This research will assess the accuracy of the Toronto Bedside Swallowing Screening Test (TOR-BSST), a new dysphagia screening test for patients with stroke. The purpose of the TOR-BSST is to predict the presence of dysphagia in stroke patients across their continuum of care in a simple and efficient manner. This initial research will assess the accuracy of the TOR-BSST in the acute and rehabilitative settings using videofluoroscopy as the gold standard for comparison. The results from this research will also assess the stability of the TOR-BSST across nursing, its primary user, and generate an estimate for the prevalence of dysphagia in adult stroke patients in the acute and rehabilitative settings. Participants in this research will be 315 stroke patients from several teaching centres in Ontario, namely 105 acute patients from the University Health Network, Sunnybrook \& Women's College Health Sciences Centre, and Hamilton General Hospital, and 210 patients in the rehabilitation setting from the Toronto Rehabilitation Institute and Parkwood Hospital, London. Both the TOR-BSST and videofluoroscopic assessment will be administered within 24 hours of each other and interpreted according to published preferred practice guidelines for dysphagia. This research will be the first to implement and assess a standardised method for screening for dysphagia in stroke patients across the continuum of stroke recovery.


Eligibility criteria: Inclusion Criteria:

* patients with a new diagnosis of brainstem or cerebellar stroke
* patients with a new diagnosis of cortical stroke with NIH Stroke Scale score of 4 or above

Exclusion Criteria:

* patients with a previous history of stroke with dysphagia
* patients with a confirmed history of Parkinson's, Parkinsonian Syndrome, ALS, MSA, MS, dementia, or other neurodegenerative disease
* patients with a history of cranial neurosurgery
* patients with a known previous or current oropharyngeal dysphagia due to structural or neurological cause
* patients with active COPD or current pneumonia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: London
country: Canada
facility: Parkwood Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook and Women's College Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital, University Health Network
state: Ontario
Study officials:
affiliation: University of Toronto
name: Rosemary Martino, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Nicholas E Diamant, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.
citation: Martino R, Pron G, Diamant N. Screening for oropharyngeal dysphagia in stroke: insufficient evidence for guidelines. Dysphagia. 2000 Winter;15(1):19-30. doi: 10.1007/s004559910006.