跳至主要内容
临床试验/NCT05473169
NCT05473169Unknown不适用

Evaluation of Swallowing in Patients With Vocal Folds Immobility

Assiut University0 个研究点目标入组 40 人开始时间: 2022年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
To calculate the incidence of swallowing dysfunction in people with vocal fold immobility

研究概览

简要总结

Vocal fold immobility (VFI) often results in significant problems with dysphonia, dysphagia, and decreased cough strength. As one element of the dysphagia potentially associated with vocal fold immobility,

aspiration may create significant morbidity for these patients. An estimated 38% to 53% of patients with

untreated VFI have swallowing difficulties with aspiration.

Vocal fold immobility has important implication on the laryngeal airway protection during respiration,

phonation and swallowing. It is the most common neurological laryngeal disorder.

The immobility may be caused by neck and thoracic surgery. which can impair the innervation of the pharynx,

upper esophageal sphincter (U.E.S) and proximal esophagus but may also be due to malignancy,trauma,

Intracranial causes,or may be idiopathic

详细描述

Besides the voice alteration, the lesion that causes of vocal fold immobility should also affect the pharyngeal phase of swallowing.

It was suggested that dysphagia in patient with vocal fold immobility has multifactor causes ; including limited airway protection and decrease laryngopharyngeal sensation based on the finding of the flexible endoscopy.

Another study revealed that pharyngeal phase abnormalities such as delayed initiation of swallowing, reduced laryngeal elevation, and reduced upper esophageal sphincter (UES) opening were found in video fluoroscopic swallowing studies (VFSS).

Several studies on the swallowing difficulties of patient with vocal fold immobility has been performed and reported that nearly 56% of these patients immobility have swallowing dysfunction.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Gender:both sexes will be included in the study.

排除标准

  • patients with structural abnormalities of oral cavity, pharynx or larynx.
  • previous vocal fold injection or voice therapy.
  • other causes of dysphagia: esophageal cancer or spasm , gastric cancer, cancer larynx,or radio therapy .
  • . Patients with history of heart burn , acid regurgitation ,
  • other neurological disease ,stroke, hypothyroidism or dyspnea.

结局指标

主要结局

To calculate the incidence of swallowing dysfunction in people with vocal fold immobility

时间窗: Baseline

Incidence of swallowing dysfunction in patients with vocal fold immobility will be determined by the Statistical Package for the Social Sciences (SPPS) after the diagnosis of swallowing dysfunction by fiberoptic endoscopic evaluation of swallowing (FEES) and videofluoroscopic swallow study (VFSS)

次要结局

  • Measure the frequency of each swallowing phase which will be affected in vocal fold immobility patients(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Zakaria Ahmed Elbakry

Principal investigator

Assiut University

相似试验