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

Not Applicable

• Conditions: Dysphagia Following Cerebral Infarction
• Interventions: Procedure: Fiberoptic endoscopic evaluation of swallowing (FEES)

• Registration Number: NCT03441932
• Lead Sponsor: Saint-Joseph University

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.

Study Timeline

• Study First Submitted: 2018-01-18
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-15
• Last Update Submitted: 2018-02-15
• Study First Posted: 2018-02-22
• Last Update Posted: 2018-02-22
• Study Start: 2018-03
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dysphagia screening failed arm	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	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

Primary Outcome Measures

Name	Time	Method
incidence of Aspiration pnemonia	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