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

Dysphagia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411306
• Other study ID #: 110957
• Status: Completed
• Phase: N/A
• First received: August 4, 2011
• Last updated: October 27, 2016
• Start date: May 2011

Study information

• Verified date: October 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

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©.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Inter-rater reliability of the TOR-BSST©	Inter-rater reliability will be calculated using the intraclass correlation coefficient (ICC).	24 hours	No
Secondary	Estimation of the incidence of dysphagia in adult acute patients following prolonged intubation		24 hours	No
Secondary	Description of the impairment characteristics of dysphagia in adult acute patients following prolonged intubation		24 hours	No

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