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

Primary Purpose

Dysphagia Following Cerebral Infarction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fiberoptic endoscopic evaluation of swallowing (FEES)
Sponsored by
Saint-Joseph University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dysphagia Following Cerebral Infarction focused on measuring Dysphagia, Pharyngeal residue scale, Stroke, Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Dysphagia screening failed arm

    Dysphagia screening passed arm

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    January 18, 2018
    Last Updated
    February 15, 2018
    Sponsor
    Saint-Joseph University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03441932
    Brief Title
    Evaluation of Morbidity and Mortality Associated With Dysphagia in Stroke Patients Based on Pharyngeal Residue Severity
    Official Title
    Evaluation of Morbidity and Mortality Associated With Dysphagia in Stroke Patients Based on Pharyngeal Residue Severity: A Prospective Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2018 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Saint-Joseph University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dysphagia Following Cerebral Infarction
    Keywords
    Dysphagia, Pharyngeal residue scale, Stroke, Pneumonia

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Non-Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dysphagia screening failed arm
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Dysphagia screening passed arm
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    Fiberoptic endoscopic evaluation of swallowing (FEES)
    Intervention Description
    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".
    Primary Outcome Measure Information:
    Title
    incidence of Aspiration pnemonia
    Description
    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
    Time Frame
    From date of inclusion till 1 year post inclusion in the study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    HUSEIN SMAYLI, M.D
    Phone
    96170817106
    Email
    hussein.smayli@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    HUSEIN SMAYLI, M.D
    Organizational Affiliation
    Hotêl-Dieu de France university hospital, Saint Joseph University, Beirut, Lebanon
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19362752
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26753927
    Citation
    Neubauer 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.
    Results Reference
    result

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

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