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

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.

Study Overview

• Status: Completed
• Conditions: Dysphagia
• Intervention / Treatment: Other: Toronto Bedside Swallowing Screening Test (TOR-BSST©); Procedure: Videofluoroscopic Swallow Study

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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©.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validity of the TOR-BSST©	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.	24 hours
Inter-rater reliability of the TOR-BSST©	Inter-rater reliability will be calculated using the intraclass correlation coefficient (ICC).	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Estimation of the incidence of dysphagia in adult acute patients following prolonged intubation	24 hours
Description of the impairment characteristics of dysphagia in adult acute patients following prolonged intubation	24 hours

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Rosemary Martino, PhD, University of Toronto / University Health Network

Publications and helpful links

General Publications

• Skoretz SA, Flowers HL, Martino R. The incidence of dysphagia following endotracheal intubation: a systematic review. Chest. 2010 Mar;137(3):665-73. doi: 10.1378/chest.09-1823.
• Barker J, Martino R, Reichardt B, Hickey EJ, Ralph-Edwards A. Incidence and impact of dysphagia in patients receiving prolonged endotracheal intubation after cardiac surgery. Can J Surg. 2009 Apr;52(2):119-24.
• Martino R, Silver F, Teasell R, Bayley M, Nicholson G, Streiner DL, Diamant NE. The Toronto Bedside Swallowing Screening Test (TOR-BSST): development and validation of a dysphagia screening tool for patients with stroke. Stroke. 2009 Feb;40(2):555-61. doi: 10.1161/STROKEAHA.107.510370. Epub 2008 Dec 12.
• Heffner JE. Swallowing complications after endotracheal extubation: moving from "whether" to "how". Chest. 2010 Mar;137(3):509-10. doi: 10.1378/chest.09-2477. No abstract available.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: August 4, 2011
• First Submitted That Met QC Criteria: August 5, 2011
• First Posted (Estimate): August 8, 2011

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 110957