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临床试验/NCT03328702
NCT03328702已完成不适用

Utilization of Continuous Positive Airway Pressure to Improve Swallow Function in Patients Post Total Laryngectomy

University of California, Davis2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2016年6月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
Total Pharyngeal Transit Time (With CPAP)

研究概览

简要总结

Investigator initiated prospective study to determine whether use of Continuous Positive Airway Pressure (CPAP) can improve the swallow function in patients who underwent total laryngectomy and are experiencing difficulty swallowing

详细描述

Total laryngectomy is a procedure that involves surgical removal of the larynx and separation of the digestive and airway tracts. The procedure is typically conducted for cases of laryngeal cancer and intractable aspiration. Following this procedure, patients are no longer at risk for aspiration; however some patients continue to experience difficulties in propulsion of food or drink throughout the pharynx. Previous research has demonstrated a reduction in pharyngeal contractile pressure and increased pharyngeal transit time in patients post laryngectomy. Continuous Positive Airway Pressure (CPAP) may assist bolus propulsion in these patients by increasing pressure in the direction of bolus flow. This study aims to evaluate the utility of a CPAP mask to improve pharyngeal swallow outcomes during Video Fluoroscopic Swallowing Exam (VFSE) in patients with dysphagia following total laryngectomy. This specific population could be well-suited for this application, since the digestive tract and airway are completely separate and there is no risk of the aspiration into the airway.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

  • Patients at least 2 months after total laryngectomy
  • Undergoing Video Fluoroscopic Swallowing Examination

排除标准

  • Patients with 100% neopharyngeal stenosis
  • Patients with active cancer within 2 months of the study
  • Patients with pharyngocutaneous fistula
  • Vulnerable population: Adults unable to consent, Pregnant women, and Prisoners

结局指标

主要结局

Total Pharyngeal Transit Time (With CPAP)

时间窗: During VFSE (1 day)

This is the time in seconds that it takes for a bolus to move from the oral cavity, through the pharynx, and into the so. It is measured in seconds and is the primary outcome measure.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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