Dysphagia Following Cerebral InfarctionNCT03441932
Evaluation of Morbidity and Mortality Associated With Dysphagia in Stroke Patients Based on Pharyngeal Residue Severity
A study testing Fiberoptic endoscopic evaluation of swallowing (FEES) in people with Dysphagia Following Cerebral Infarction, run by Saint-Joseph University.
Trial summary
Specific objectives: Evaluation of morbidity and mortality associated with the severity of pharyngeal residue in patients admitted to Hotêl-Dieu de France university hospital for Stroke based on the "The Yale pharyngeal residue scale" Evaluation of the accuracy of screening protocol of Dysphagia at the Emergency… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia Following Cerebral Infarction
- What is being tested?
- Fiberoptic endoscopic evaluation of swallowing (FEES)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Dec 2019
- Phase
- Interventional
- 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
Who may be able to join
- Age >18 years
- Patients admitted for Stroke (Ischemic or hemorragic)
- Patients reachable by phone call
Who cannot join
- Previous history of major head and neck surgery
- Previous or actual history of treatment by chemotherapy or radiotherapy for a head and neck neoplasm
- Current Head and neck neoplasm
- Previous or current history of esophageal carcinoma
- Esophageal motility disorder
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Morbidity and Mortality Associated With Dysphagia in Stroke Patients Based on Pharyngeal Residue Severity: A Prospective Study
Specific objectives:
- Evaluation of morbidity and mortality associated with the severity of pharyngeal residue in patients admitted to Hotêl-Dieu de France university hospital for Stroke based on the "The Yale pharyngeal residue scale"
- Evaluation of the accuracy of screening protocol of Dysphagia at the Emergency Department in patients admitted for stoke based on the "Emergency Department Dysphagia Screening Tool"
Read the detailed description
Dysphagia after stroke is common, affecting 27% to 64% of patients. Complications of dysphagia include aspiration leading to chest infection and pneumonia, malnutrition, inability to rehabilitate, increased risk of infection, prolonged length of stay in hospital, and an increased risk of death.
Deglutologists who use FEES have long lamented the fact that there was no reliable, validated, anatomically defined, image-based, and easily used pharyngeal residue severity rating scale. All that one had to rely on was the "impression" of residue severity, the definition of which varied from endoscopist to endoscopist In order for any scale to gain widespread acceptance, it must be user friendly, easy to learn, reliable to interpret, and generalizable to all patients undergoing FEES. Such a scale now exists, and it is the Yale Pharyngeal Residue Severity Rating Scale
Need for a trial: The relation between the severity of the pharyngeal residue and the risk of aspiration and subsequently the morbidity and mortality in stroke patients is not well defined yet.
Thus, the purpose of this study was to determine the morbidity and mortality associated with the severity of pharyngeal residue in a specific population: stroke patients
Another objective of the study is to evaluate the accuracy of Emergency department (ED) dysphagia screening in stroke patients compared to a standard swallowing evaluation with FEES.
All patients admitted to Hotêl-Dieu de France university hospital for stroke will be evaluated for dysphagia using the ED dysphagia-screening tool. Preliminary data on the accuracy of the "ED dysphagia screening tool" are promising (Sensitivity of 96%)
In this study outcomes between 2 groups will be evaluated; (ED failed screening group and ED Screening passed group) and thus be able to validate results of previous studies concerning sensitivity and accuracy of the screening tool mentioned previously and finally to be able to identify stroke patients eligible for early oral nutrition.
- Conditions
- Dysphagia Following Cerebral Infarction
- Being tested
- Fiberoptic endoscopic evaluation of swallowing (FEES)
- Keywords
- Dysphagia, Pharyngeal residue scale, Stroke, Pneumonia
- Medical subject headings
- Deglutition Disorders, Stroke, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiberoptic endoscopic evaluation of swallowing (FEES)Procedure or surgery
Subjets within the two groups will after than have FEES with videotaping of pharyngeal phase after giving subjects a standardised food consisting of "thin Puree".
| Study group | Role | What they receive |
|---|---|---|
| Dysphagia screening failed arm | Active comparator | Subjets within the this arm will have FEES with videotaping of pharyngeal phase after giving subjects a standardised food consisting of "thin Puree". An ENT resident blinded to the result of the screening test will do this intervention Receives: Procedure: Fiberoptic endoscopic evaluation of swallowing (FEES) |
| Dysphagia screening passed arm | Active comparator | Subjets within the this arm will have FEES with videotaping of pharyngeal phase after giving subjects a standardised food consisting of "thin Puree". An ENT resident blinded to the result of the screening test will do this intervention Receives: Procedure: Fiberoptic endoscopic evaluation of swallowing (FEES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of Aspiration pnemonia
Evaluation of aspiration pneumonia risk associated with the severity of pharyngeal residue in patients admitted to Hotêl-Dieu de France university hospital for Stroke based on the "The Yale pharyngeal residue scale".
The Yale Pharyngeal Residue Severity Rating Scale can be used for both clinical advantages and research opportunities.
Clinically, clinicians can now accurately classify vallecula and pyriform sinus residue severity as none, trace, mild, moderate, or severe for diagnostic purposes, determination of functional therapeutic change, and evaluation of prognosis
Measured: From date of inclusion till 1 year post inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study startMar 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dysphagia Following Cerebral InfarctionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- * Dysphagia screening in the Emergency department for any patient admitted to Hotêl-Dieu de France university hospital for Stroke based on the " Emergency department dysphagia-screening tool". * Subjets will be then sorted in two groups: \> 1-Screening passed \> 2-Screening failed • Subjets within the two groups will after than have FEES with videotaping of pharyngeal phase after giving subjects a standardised food consisting of "thin Puree". An ENT resident blinded to the result of the screening test will do this intervention.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HUSEIN SMAYLI, M.D, Principal investigator, Hotêl-Dieu de France university hospital, Saint Joseph University, Beirut, Lebanon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441932
- Sponsor's protocol ID
- SaintJU
- Status last verified
- Feb 2018
- First submitted
- 18 Jan 2018
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turner-Lawrence DE, Peebles M, Price MF, Singh SJ, Asimos AW. A feasibility study of the sensitivity of emergency physician Dysphagia screening in acute stroke patients. Ann Emerg Med. 2009 Sep;54(3):344-8, 348.e1. doi: 10.1016/j.annemergmed.2009.03.007. Epub 2009 Apr 11.
PubMed 19362752Neubauer PD, Hersey DP, Leder SB. Pharyngeal Residue Severity Rating Scales Based on Fiberoptic Endoscopic Evaluation of Swallowing: A Systematic Review. Dysphagia. 2016 Jun;31(3):352-9. doi: 10.1007/s00455-015-9682-6. Epub 2016 Jan 11.
PubMed 26753927
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Morbidity and Mortality Associated With Dysphagia in Stroke Patients Based on Pharyngeal Residue Severity: A Prospective Study
- ClinicalTrials.gov ID
- NCT03441932
- Acronym / sponsor ID
- SaintJU
- Conditions
- Dysphagia Following Cerebral Infarction
- Keywords
- Dysphagia, Pharyngeal residue scale, Stroke, Pneumonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 22 Feb 2018 (actual)
- 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.
Specific objectives:
- Evaluation of morbidity and mortality associated with the severity of pharyngeal residue in patients admitted to Hotêl-Dieu de France university hospital for Stroke based on the "The Yale pharyngeal residue scale"
- Evaluation of the accuracy of screening protocol of Dysphagia at the Emergency Department in patients admitted for stoke based on the "Emergency Department Dysphagia Screening Tool"
Detailed description
Dysphagia after stroke is common, affecting 27% to 64% of patients. Complications of dysphagia include aspiration leading to chest infection and pneumonia, malnutrition, inability to rehabilitate, increased risk of infection, prolonged length of stay in hospital, and an increased risk of death.
Deglutologists who use FEES have long lamented the fact that there was no reliable, validated, anatomically defined, image-based, and easily used pharyngeal residue severity rating scale. All that one had to rely on was the "impression" of residue severity, the definition of which varied from endoscopist to endoscopist In order for any scale to gain widespread acceptance, it must be user friendly, easy to learn, reliable to interpret, and generalizable to all patients undergoing FEES. Such a scale now exists, and it is the Yale Pharyngeal Residue Severity Rating Scale
Need for a trial: The relation between the severity of the pharyngeal residue and the risk of aspiration and subsequently the morbidity and mortality in stroke patients is not well defined yet.
Thus, the purpose of this study was to determine the morbidity and mortality associated with the severity of pharyngeal residue in a specific population: stroke patients
Another objective of the study is to evaluate the accuracy of Emergency department (ED) dysphagia screening in stroke patients compared to a standard swallowing evaluation with FEES.
All patients admitted to Hotêl-Dieu de France university hospital for stroke will be evaluated for dysphagia using the ED dysphagia-screening tool. Preliminary data on the accuracy of the "ED dysphagia screening tool" are promising (Sensitivity of 96%)
In this study outcomes between 2 groups will be evaluated; (ED failed screening group and ED Screening passed group) and thus be able to validate results of previous studies concerning sensitivity and accuracy of the screening tool mentioned previously and finally to be able to identify stroke patients eligible for early oral nutrition.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Dysphagia screening in the Emergency department for any patient admitted to Hotêl-Dieu de France university hospital for Stroke based on the " Emergency department dysphagia-screening tool". * Subjets will be then sorted in two groups: > 1-Screening passed > 2-Screening failed • Subjets within the two groups will after than have FEES with videotaping of pharyngeal phase after giving subjects a standardised food consisting of "thin Puree". An ENT resident blinded to the result of the screening test will do this intervention.
| Arm | Type | Receives |
|---|---|---|
| Dysphagia screening failed arm | Active comparator | Procedure: Fiberoptic endoscopic evaluation of swallowing (FEES)Subjets within the this arm will have FEES with videotaping of pharyngeal phase after giving subjects a standardised food consisting of "thin Puree". An ENT resident blinded to the result of the screening test will do this intervention |
| Dysphagia screening passed arm | Active comparator | Procedure: Fiberoptic endoscopic evaluation of swallowing (FEES)Subjets within the this arm will have FEES with videotaping of pharyngeal phase after giving subjects a standardised food consisting of "thin Puree". An ENT resident blinded to the result of the screening test will do this intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Patients admitted for Stroke (Ischemic or hemorragic)
- Patients reachable by phone call
Key exclusion criteria (5 listed)
- Previous history of major head and neck surgery
- Previous or actual history of treatment by chemotherapy or radiotherapy for a head and neck neoplasm
- Current Head and neck neoplasm
- Previous or current history of esophageal carcinoma
- Esophageal motility disorder
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 |
|---|---|---|
| Fiberoptic endoscopic evaluation of swallowing (FEES)Subjets within the two groups will after than have FEES with videotaping of pharyngeal phase after giving subjects a standardised food consisting of "thin Puree". | Procedure or surgery | Dysphagia screening failed arm, Dysphagia screening passed arm |
Primary outcome
incidence of Aspiration pnemonia
Time frame: From date of inclusion till 1 year post inclusion in the study
Evaluation of aspiration pneumonia risk associated with the severity of pharyngeal residue in patients admitted to Hotêl-Dieu de France university hospital for Stroke based on the "The Yale pharyngeal residue scale". The Yale Pharyngeal Residue Severity Rating Scale can be used for both clinical advantages and research opportunities. Clinically, clinicians can now accurately classify vallecula and pyriform sinus residue severity as none, trace, mild, moderate, or severe for diagnostic purposes, determination of functional therapeutic change, and evaluation of prognosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Background: PubMed 19362752Turner-Lawrence DE, Peebles M, Price MF, Singh SJ, Asimos AW. A feasibility study of the sensitivity of emergency physician Dysphagia screening in acute stroke patients. Ann Emerg Med. 2009 Sep;54(3):344-8, 348.e1. doi: 10.1016/j.annemergmed.2009.03.007. Epub 2009 Apr 11.
- Results publication: PubMed 26753927Neubauer PD, Hersey DP, Leder SB. Pharyngeal Residue Severity Rating Scales Based on Fiberoptic Endoscopic Evaluation of Swallowing: A Systematic Review. Dysphagia. 2016 Jun;31(3):352-9. doi: 10.1007/s00455-015-9682-6. Epub 2016 Jan 11.
- Individual participant dataSharing planned: No
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.
HUSEIN SMAYLI, M.D principal investigator
Hotêl-Dieu de France university hospital, Saint Joseph University, Beirut, Lebanon
Questions about this trial
What is this clinical trial studying?
A study testing Fiberoptic endoscopic evaluation of swallowing (FEES) in people with Dysphagia Following Cerebral Infarction, run by Saint-Joseph University.
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 5 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: status not confirmed, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HUSEIN SMAYLI, M.D (96170817106, hussein.smayli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of Aspiration pnemonia (time frame: From date of inclusion till 1 year post inclusion in the study). 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 NCT03441932, which also lists 2 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 22 Feb 2018.