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临床试验/NCT03891940
NCT03891940Unknown不适用

Evaluation of Changes of Swallowing Motor Function After Cervical Spine Surgery With Anterior Approach- the Implication of High Resolution Impedance Manometry

National Taiwan University Hospital0 个研究点目标入组 30 人开始时间: 2019年3月26日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
upper esophageal sphincter pressure changes

研究概览

简要总结

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

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

we aimed to observe the changes and recovery course swallowing function parameters during the preoperative and postoperative period in the patients receiving anterior cervical spine surgery by HRIM and ultrasonography.

详细描述

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

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

We aimed to observe the changes and recovery course swallowing function parameters during the preoperative and postoperative period in the patients receiving anterior cervical spine surgery by HRIM and ultrasonography. 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 ultrasonography and 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, 1 week, and 1 months, 3 months (If needed) by HRIM and ultrasonography.

研究设计

研究类型
Observational
观察模型
Cohort
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 anterior 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

upper esophageal sphincter pressure changes

时间窗: everage 1 month in the perioperative period

upper esophageal sphincter pressure changes measured by the HRIM

次要结局

  • hyoid bone movement(everage 1 month in the perioperative period)

研究者

申办方类型
Other
责任方
Sponsor

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