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临床试验/NCT04123522
NCT04123522Unknown不适用

Using the High Resolution Impedance Manometry to Evaluate Swallowing Function After Cervical Spine Surgery: Anterior vs Posterior Approach

National Taiwan University Hospital0 个研究点目标入组 24 人开始时间: 2019年11月2日最近更新:
适应症

试验速览

阶段
不适用
入组人数
24
主要终点
mean pharyngeal peak pressure

研究概览

简要总结

Dysphagia is a well-known complication following cervical spine surgery, including anterior or posterior approach. However, which muscle at oropharyngeal region weakness and the recovery course of these patients are still unknown.

The high resolution impedance manometry (HRIM) could be used to measure the postoperative recovery esophageal function.

详细描述

Dysphagia is a well-known complication following cervical spine surgery, including anterior or posterior approach. However, which muscle at oropharyngeal region weakness and the recovery course of these patients are still unknown.

The high resolution impedance manometry (HRIM) could be used to measure the postoperative recovery esophageal function.

In this study, using the high resolution impedance manometry to determine (1) whether the occurrence of dysphagia in the postoperative 1 or 7 days and 1 month in the patients receiving anterior vs posterior approach of cervical spine surgery (2) which muscle in the pharyngeal region would be destroyed Consecutive patients who will fulfill the criteria of cervical spine surgery patients under general anesthesia and aged >= 20 will be enrolled. The patients would receive the dysphagia questionnaire. All subjects would receive the swallowing function by HRIM before the surgeries. The cough test was also measured. After the surgery, the patient would be followed the swallowing function in the postoperative one day, and 1 week by HRIM and questionnaire.

This study would expect (1) that the posterior cervical spine surgery would result in dysphagia greater than baseline, but less than that of anterior cervical procedures; (2) decreasing upper esophageal sphincter (UES) pressure may be the reason of postoperative dysphagia in the anterior cervical spine surgery, resulted from the intraoperative traction; (3) decreasing hypopharyngeal muscle pressure may be the reason of postoperative dysphagia in the posterior spine surgery, resulted from the prone and flexion positioning.

研究设计

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

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who fulfill the criteria of cervical spine surgery under general anesthesia
  • Aged from 20-80 years old -

排除标准

  • Major systemic disease, such as congestive heart failure, liver cirrhosis, end stage renal disease and malignancy.
  • Patients who have the risk of difficult ventilation or intubation.
  • pregnant women
  • coagulopathy

结局指标

主要结局

mean pharyngeal peak pressure

时间窗: preoperative, postoperative day 1 and 7

the pharyngeal presssure change during swallowing

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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