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临床试验/NCT06465355
NCT06465355撤回不适用

The Role of Swallowing An Air Bolus on Primary Esophageal Peristalsis

Medical College of Wisconsin2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年10月10日最近更新:
适应症

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

  1. All the study subjects are required to be without oral food or fluid intake for at least 3 hours prior to the study
  2. 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.
  3. 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.
  4. Following completion of the study, the manometry catheter and the single lumen tube will be removed.
  5. The participant will also be instructed to resume their regular diet and activity.
  6. 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

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

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

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

研究点 (2)

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