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

NCT01411306 | Completed

• 1 other identifier: 110957
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (1)

Med/Surg ICU Inpatients, Intubated ≥ 48 hours

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

Interventions

Toronto Bedside Swallowing Screening Test (TOR-BSST©) OTHER

All enrolled patients will be screened for dysphagia by two blinded screeners using the TOR-BSST©.

Med/Surg ICU Inpatients, Intubated ≥ 48 hours

Videofluoroscopic Swallow Study PROCEDURE

All enrolled patients will undergo a videofluoroscopic assessment of swallowing within 24 hours of being screened with the TOR-BSST©.

Med/Surg ICU Inpatients, Intubated ≥ 48 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• History of one or more of the following: neurological disorder, surgery to the head or neck, previous oropharyngeal dysphagia, tracheotomy in situ or dementia

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related 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.

  PMID: 19399206 BACKGROUND

• 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.

  PMID: 19074483 BACKGROUND

• 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.

  PMID: 20202948 BACKGROUND

• 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.

  PMID: 20202944 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Rosemary Martino, PhD

  University of Toronto / University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2011
• First Posted: August 8, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2015
• Last Updated: October 31, 2016

Record last verified: 2016-10

Locations

CA (1)