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临床试验/NCT03495219
NCT03495219撤回不适用

Subjects Ability to Control Pressure in the Lower Esophageal High Pressure Znoe (HPZ) During Manometry.

Mayo Clinic0 个研究点开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
Mayo Clinic
主要终点
Reduction in Reflux Symptom Index Score (RSI)

研究概览

简要总结

To establish to what degree individuals can increase esophageal high pressure zone (HPZ) after instruction in deep breathing as evidenced by concurrent manometric pressure readings.

详细描述

Pressure in the lower esophagus has been negatively associated with reflux symptoms: the lower the pressure, the more reflux symptoms. This pressure can be augmented with deep abdominal breathing. This can be detected during esophageal manometry, when a pressure catheter is placed into the esophagus. Manometry is routinely done for swallowing disorders.

This study will take place just after a routine manometry test, when the subject still has the catheter in place. All that is required for the research portion is to observe manometry readings while they breathe, then when they deep breath, then breathe after they have been cued or coached to deep abdominal breathing. This is done in sequence to establish how quickly this pressure can be improved.

This coached breathing is then prescribed as a routine exercise and long term follow up performed via phone to see how their reflux symptoms have responded.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Eligibility is forwarded to all individuals undergoing routine esophageal manometry. They would have had to have met all eligibility criteria for this procedure.
  • Exclusion criteria:
  • Individuals undergoing modified barium swallow studies (MBSS). Exclusion from MBSS would preclude inclusion in this study.

排除标准

  • 未提供

结局指标

主要结局

Reduction in Reflux Symptom Index Score (RSI)

时间窗: 3 months.

Does intervention reduce RSI score from before intervention to follow up.

次要结局

  • Association of RSI to resting manometry pressure in the lower esophagus(1 day)
  • Can lower esophageal pressure can be increased by instruction/coaching by a physical therapist.(1 day)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

C. Joseph Yelvington P.T., D.P.T.

Principal Investigator

Mayo Clinic

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