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Evaluation of Morbidity and Mortality Associated With Dysphagia in Stroke Patients Based on Pharyngeal Residue Severity

Evaluation of Morbidity and Mortality Associated With Dysphagia in Stroke Patients Based on Pharyngeal Residue Severity: A Prospective Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03441932
Enrollment
150
Registered
2018-02-22
Start date
2018-03-31
Completion date
2019-12-31
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia Following Cerebral Infarction

Keywords

Dysphagia, Pharyngeal residue scale, Stroke, Pneumonia

Brief 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 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.

Interventions

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.

Sponsors

Saint-Joseph University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \>18 years * Patients admitted for Stroke (Ischemic or hemorragic) * Patients reachable by phone call

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
incidence of Aspiration pnemoniaFrom date of inclusion till 1 year post inclusion in the studyEvaluation 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

Contacts

Primary ContactHUSEIN SMAYLI, M.D
hussein.smayli@hotmail.com96170817106

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026