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临床试验/NCT03441932
NCT03441932Unknown不适用

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

Saint-Joseph University0 个研究点目标入组 150 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
150
主要终点
incidence of Aspiration pnemonia

研究概览

简要总结

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"

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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

干预措施: Fiberoptic endoscopic evaluation of swallowing (FEES) (Procedure)

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

干预措施: Fiberoptic endoscopic evaluation of swallowing (FEES) (Procedure)

结局指标

主要结局

incidence of Aspiration pnemonia

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Saint-Joseph University
申办方类型
Other
责任方
Sponsor

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