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

Completed

• Conditions: Dysphagia
• Interventions: Other: Toronto Bedside Swallowing Screening Test (TOR-BSST©); Procedure: Videofluoroscopic Swallow Study

• Registration Number: NCT01411306
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-08-04
• Study First Submitted QC: 2011-08-05
• Study First Posted: 2011-08-08
• Primary Completion: 2015-11
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Med/Surg ICU Inpatients, Intubated ≥ 48 hours	Toronto Bedside Swallowing Screening Test (TOR-BSST©)	-
Med/Surg ICU Inpatients, Intubated ≥ 48 hours	Videofluoroscopic Swallow Study	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada