Screening for Swallowing Problems in Patients Following Prolonged Intubation: Validation of the Toronto Bedside Swallowing Screening Test (TOR-BSST©)

This study is currently recruiting participants.
Verified June 2012 by University Health Network, Toronto
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01411306
First received: August 4, 2011
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

Despite medical advances, half of the patients admitted to hospital for recovery from acute illness, injury or surgery have swallowing difficulties and those requiring tubes for breathing support are at even greater risk. Difficulties with swallowing decrease patients' quality of life, prolong their hospital stay, as well as lead to medical complications such as pneumonia, malnutrition and death. Presently, there is no screening test for swallowing difficulties in patients who have required respiratory support. Screening will allow for early detection of swallowing problems which is important to prevent serious complications, such as pneumonia. This research will determine the accuracy of a new screening test, the Toronto Bedside Swallowing Screening Test (TOR-BSST©) previously tested with stroke patients, to predict the presence of swallowing difficulties in patients who have required breathing support for longer than 48 hours. The investigators will enroll 100 patients from the intensive care medical surgical units at the University Health Network. The findings from this research will help identify those patients with swallowing problems earlier than it is currently possible. Once identified, at risk patients will be referred to a speech language pathologist swallowing expert for more comprehensive testing; thereby, decreasing their risk of experiencing serious complications, such as pneumonia, secondary to swallowing problems.


Condition Intervention
Dysphagia
Other: Toronto Bedside Swallowing Screening Test (TOR-BSST©)
Procedure: Videofluoroscopic Swallow Study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Validity of the TOR-BSST© [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The validity of the TOR-BSST© will be measured using sensitivity, specificity, likelihood ratios, positive predictive value (PPV), and negative predictive value (NPV). Results of the videofluoroscopic assessment of swallowing will be used as the gold standard comparison.

  • Inter-rater reliability of the TOR-BSST© [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Inter-rater reliability will be calculated using the intraclass correlation coefficient (ICC).


Secondary Outcome Measures:
  • Estimation of the incidence of dysphagia in adult acute patients following prolonged intubation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Description of the impairment characteristics of dysphagia in adult acute patients following prolonged intubation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2011
Groups/Cohorts Assigned Interventions
Med/Surg ICU Inpatients, Intubated ≥ 48 hours Other: Toronto Bedside Swallowing Screening Test (TOR-BSST©)
All enrolled patients will be screened for dysphagia by two blinded screeners using the TOR-BSST©.
Procedure: Videofluoroscopic Swallow Study
All enrolled patients will undergo a videofluoroscopic assessment of swallowing within 24 hours of being screened with the TOR-BSST©.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Med/Surg ICU inpatients who have received endotracheal intubation lasting 48 hours or longer

Criteria

Inclusion Criteria:

  • Adults 18+ years
  • Inpatient at University Health Network, in any of the medical-surgical intensive care units, regardless of disease type, comorbidities or previous medical history
  • Received endotracheal intubation lasting 48 hours or longer

Exclusion Criteria:

  • History of one or more of the following: neurological disorder, surgery to the head or neck, previous oropharyngeal dysphagia, tracheotomy in situ or dementia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411306

Contacts
Contact: Trixie Reichardt, MHSc 416-603-5800 ext 3913 trixie.reichardt@uhnresearch.ca
Contact: Rosemary Martino, PhD 416-946-8644 rosemary.martino@utoronto.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Rosemary Martino, PhD    416-946-8644    rosemary.martino@utoronto.ca   
Principal Investigator: Rosemary Martino, PhD         
Sponsors and Collaborators
University Health Network, Toronto
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Rosemary Martino, PhD University of Toronto / University Health Network