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

NCT03441932 | Unknown

• 1 other identifier: SaintJU
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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"

Conditions

Dysphagia Following Cerebral Infarction

Keywords

Dysphagia; Pharyngeal residue scale; Stroke; Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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

  From date of inclusion till 1 year post inclusion in the study

Study Arms (2)

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

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

Procedure: Fiberoptic endoscopic evaluation of swallowing (FEES)

Interventions

Fiberoptic endoscopic evaluation of swallowing (FEES) PROCEDURE

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".

Dysphagia screening failed arm; Dysphagia screening passed arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint-Joseph University: lead

Related Publications (2)

• 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.

  PMID: 19362752 BACKGROUND

• 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.

  PMID: 26753927 RESULT

MeSH Terms

Conditions

Deglutition Disorders; Stroke; Pneumonia

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• HUSEIN SMAYLI, M.D

  Hotêl-Dieu de France university hospital, Saint Joseph University, Beirut, Lebanon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HUSEIN SMAYLI, M.D

CONTACT

96170817106; hussein.smayli@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * 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.

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: February 22, 2018
• Study Start: March 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 22, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share