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

NCT ID: NCT01411306

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dysphagia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Med/Surg ICU Inpatients, Intubated ≥ 48 hours

Toronto Bedside Swallowing Screening Test (TOR-BSST©)

Intervention Type OTHER

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

Videofluoroscopic Swallow Study

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Toronto Bedside Swallowing Screening Test (TOR-BSST©)

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

Intervention Type OTHER

Videofluoroscopic Swallow Study

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rosemary Martino, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto / University Health Network

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Health Network

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 19399206 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19074483 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20202948 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20202944 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

110957

Identifier Type: -

Identifier Source: org_study_id