The Role of Swallowing An Air Bolus on Primary Esophageal Peristalsis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- smooth esophageal muscle contractile integral
研究概览
简要总结
Understanding the correlation between the transmission of a bolus from the pharynx into the proximal esophagus and activating primary esophageal peristalsis.
详细描述
Study Procedures and Analyses
- All the study subjects are required to be without oral food or fluid intake for at least 3 hours prior to the study
- After application of local lidocaine, the high resolution manometry (HRM) catheter will be inserted through the more patent nares and positioned such that it covers the pharynx and the esophagus. Affixed to the high resolution catheter will be a single lumen, end-hole catheter (length: 90 cm, outside diameter: 1.58 mm) wherein the end hole of the tube will be secured at a fixed pharyngeal site on the HRM catheter and the other end of the tube will be connected to a stopcock so that the tube may be either open or closed to atmospheric pressure.
- Study subjects will be asked to swallow their ambient saliva ten times with the stopcock open and ten times with the stopcock closed. There is a 30 second interval between swallows.
- Following completion of the study, the manometry catheter and the single lumen tube will be removed.
- The participant will also be instructed to resume their regular diet and activity.
- All the pressure recordings will be analyzed by two individuals in a blinded fashion.
The investigators will compare motility pressure metrics like striated esophageal muscle contractile integral, esophageal smooth muscle contractile integral, peristaltic wave velocity and esophageal clearance time to evaluate the potential differences in esophageal motility metrics when an air bolus is allowed to flow into the esophagus compared to those metrics when air is shunted out of the pharynx by a trans-nasal tube vented to the atmosphere.
Statistical analysis will be performed in a repeated measures technique comparing metrics with and without the pharyngeal shunt stopcock closed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subject with no history or present diagnosis of pharyngo-esophageal diseases or motility disorders
- •Age 21 to 90 years
排除标准
- •Under the age of 21
- •Over the age of 90
- •Presence of pharyngo-esophageal disease or motility disorders
- •Pregnancy
- •Lidocaine allergy
结局指标
主要结局
smooth esophageal muscle contractile integral
时间窗: through study completion, an average of 1 year
Motility pressure metric to measure contractile vigor of the distal esophagus in mmHg-cm-seconds
peristaltic wave velocity
时间窗: through study completion, an average of 1 year
average speed at which the primary peristaltic pressure wave traverses the esophagus in cm/second
esophageal clearance time
时间窗: through study completion, an average of 1 year
time for the entire swallowed bolus to travers the esophagus in seconds
striated esophageal muscle contractile integral
时间窗: through study completion, an average of 1 year
Motility pressure metric to measure contractile vigor of the proximal esophagus in mmHg-cm-seconds
次要结局
未报告次要终点
研究者
Reza Shaker, MD
Associate Provost for Clinical and Translational Research, Senior Associate Dean and Director of the Clinical and Translational Science Institute of SE WI, and the Joseph E. Geenen Professor and Chief of Gastroenterology and Hepatology
Medical College of Wisconsin
