DysphagiaNCT01411306
Screening for Swallowing Problems in Patients Following Prolonged Intubation: Validation of the Toronto Bedside Swallowing Screening Test (TOR-BSST©)
An observational study of Dysphagia, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- Toronto Bedside Swallowing Screening Test (TOR-BSST©) and Videofluoroscopic Swallow Study
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Med/Surg ICU inpatients who have received endotracheal intubation lasting 48 hours or longer
Who may be able to join
- 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
Who cannot join
- History of one or more of the following: neurological disorder, surgery to the head or neck, previous oropharyngeal dysphagia, tracheotomy in situ or dementia
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Toronto Bedside Swallowing Screening Test (TOR-BSST©), Videofluoroscopic Swallow Study
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toronto Bedside Swallowing Screening Test (TOR-BSST©)Other
All enrolled patients will be screened for dysphagia by two blinded screeners using the TOR-BSST©.
Videofluoroscopic Swallow StudyProcedure or surgery
All enrolled patients will undergo a videofluoroscopic assessment of swallowing within 24 hours of being screened with the TOR-BSST©.
| Study group | Role | What they receive |
|---|---|---|
| Med/Surg ICU Inpatients, Intubated ≥ 48 hours | Not described Receives: Other: Toronto Bedside Swallowing Screening Test (TOR-BSST©); Procedure: Videofluoroscopic Swallow Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Inter-rater reliability of the TOR-BSST©
Inter-rater reliability will be calculated using the intraclass correlation coefficient (ICC).
Measured: 24 hours
Secondary outcomes (2)
Estimation of the incidence of dysphagia in adult acute patients following prolonged intubation
Measured: 24 hours
Description of the impairment characteristics of dysphagia in adult acute patients following prolonged intubation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Rosemary Martino, PhD, Principal investigator, University of Toronto / University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411306
- Sponsor's protocol ID
- 110957
- Status last verified
- Oct 2016
- First submitted
- 4 Aug 2011
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19399206Martino 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.
PubMed 19074483Skoretz 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.
PubMed 20202948Heffner 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.
PubMed 20202944
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Swallowing Problems in Patients Following Prolonged Intubation: Validation of the Toronto Bedside Swallowing Screening Test (TOR-BSST©)
- ClinicalTrials.gov ID
- NCT01411306
- Acronym / sponsor ID
- 110957
- Conditions
- Dysphagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- May 2011
- Primary completion
- Nov 2015 (actual)
- First posted
- 8 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Med/Surg ICU Inpatients, Intubated ≥ 48 hours | – | Other: Toronto Bedside Swallowing Screening Test (TOR-BSST©), Procedure: Videofluoroscopic Swallow Study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Med/Surg ICU inpatients who have received endotracheal intubation lasting 48 hours or longer
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- History of one or more of the following: neurological disorder, surgery to the head or neck, previous oropharyngeal dysphagia, tracheotomy in situ or dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toronto Bedside Swallowing Screening Test (TOR-BSST©)All enrolled patients will be screened for dysphagia by two blinded screeners using the TOR-BSST©. | Other | Med/Surg ICU Inpatients, Intubated ≥ 48 hours |
| Videofluoroscopic Swallow StudyAll enrolled patients will undergo a videofluoroscopic assessment of swallowing within 24 hours of being screened with the TOR-BSST©. | Procedure or surgery | Med/Surg ICU Inpatients, Intubated ≥ 48 hours |
Primary outcome
Validity of the TOR-BSST©
Time frame: 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.
Inter-rater reliability of the TOR-BSST©
Time frame: 24 hours
Inter-rater reliability will be calculated using the intraclass correlation coefficient (ICC).
2 secondary outcomes
Estimation of the incidence of dysphagia in adult acute patients following prolonged intubation
Time frame: 24 hours
Description of the impairment characteristics of dysphagia in adult acute patients following prolonged intubation
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Background: PubMed 19399206Barker 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.
- Background: PubMed 19074483Martino 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.
- Background: PubMed 20202948Skoretz 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.
- Background: PubMed 20202944Heffner 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosemary Martino, PhD principal investigator
University of Toronto / University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of the TOR-BSST© (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01411306, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.