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临床试验/NCT05708885
NCT05708885招募中不适用

Characterization of the Striated Esophagus (St.Eso) Deglutitive Motor Function and Its Modulation by Pharyngeal Phase Swallow Biomechanics

Medical College of Wisconsin2 个研究点 分布在 1 个国家目标入组 557 人开始时间: 2022年9月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
557
试验地点
2
主要终点
hypopharyngeal intra-bolus

研究概览

简要总结

The investigators hypothesize that striated esophagus deglutitive motor function is modulated by pharyngeal phase swallowing biomechanics.

详细描述

To achieve the specific aim, the investigators will use state-of the-art available techniques and recording modalities alone or in combination/concurrently, as well as a novel device with proven ability to non-invasively manipulate the pharyngeal biomechanics both in a positive as well as negative way. This device and technique have been described earlier in the innovation section.

High Resolution Manometry (HRM)/Impedance recording: Pharyngeal and proximal esophageal pressure phenomena will be recorded and analyzed using a high-resolution manometric catheter (36 sensors 1 cm spacing), positioned trans-nasally to traverse the pharynx, UES, and proximal esophagus passing the transition zone) and computerized recording and analysis system. Also, manometric data will be imported to a supplementary programming environment when computational tools provided in the conventional software do not meet our analytical needs. Also configured on the high-resolution manometric probe are 18 impedance sites spaced every 2 cm to monitor bolus position. Similar to the manometric data, impedance data is also displayed by the previously described recording and analysis systems.

Concurrent high-resolution impedance manometry and digital video-fluoroscopic recording: To obtain objective quantifiable measures of peristalsis, swallow biomechanics and bolus kinematics, the investigators use high resolution impedance manometry concurrent with 30 frame/sec digital videofluoroscopy. Since our catheter also has impedance recording it will provide opportunity for additional analysis in concert with fluoroscopic recordings.

Digital video-fluoroscopy: The investigators will use digital video fluoroscopy at 30 frame/s in the sagittal or frontal view to record and subsequently analyze the deglutitive laryngeal and hyoid excursions as well as UES opening and closure data and bolus trajectory and kinematics. Video-fluoroscopic recordings will be obtained at 90 kiloelectron volt, using a 9-in. image intensifier and appropriate collimation. Based on our preliminary studies, the investigators will record 5-ml and 10-ml liquid barium swallows. Fluoroscopic sagittal images will be targeted to clearly visualize the entire pharynx, larynx, hyoid bone, upper esophageal sphincter (UES) and the proximal esophagus. A pregnancy testing will be completed prior to fluoroscopy exposure.

Technique for reducing laryngeal and striated esophagus (St.Eso) excursion: the investigators will use the swallowing resistance exercise device (sRED) to experimentally reduce the laryngeal and St.Eso excursion and UES opening.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects aged 18 to 90 years.
  • Patents with dysphagia but normal high resolution esophageal manometric findings defined by the Chicago classification.

排除标准

  • Anyone less than 18 years old.
  • Patients with recent head and neck cancer (<1 month post-surgery or <3 months post-chemo radiation.
  • Patients suffering from muscle diseases like muscular dystrophies, myopathies.
  • Patients with neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disorders.
  • Patients having history of allergy to lidocaine or barium.
  • Patients who are pregnant or lactating.
  • Patients who are medically unstable.
  • Patients who are unable to apply the exerciser independently or with the help of a caregiver.
  • Patients who lack cognition.

结局指标

主要结局

hypopharyngeal intra-bolus

时间窗: After exerciser regimen, during deglutitive restriction of the larynx

pressure within the swallowed bolus as it passes through the hypopharynx

maximum excursion of the hyo-laryngeal complex

时间窗: After six weeks exerciser regimen, during deglutitive restriction of the larynx

maximum deglutitive excursion of the hyoid and larynx from the pre-swallow resting position as measured from fluoroscopic images

pharyngeal contractile integral

时间窗: After six weeks exerciser regimen, during deglutitive restriction of the larynx

Time-space integral of the pharynx during swallows as measured from the manometric display

peak deglutitive pharyngeal peristaltic wave pressure

时间窗: After six weeks exerciser regimen, during deglutitive restriction of the larynx

Peak deglutitive pharyngeal peristaltic wave pressure will be measured at positions 2-8cm above the upper margin of the manometrically determined upper esophageal sphincter high-pressure zone (UESHPZ)

upper esophageal sphincter (UES) nadir pressure

时间窗: After six weeks exerciser regimen, during deglutitive restriction of the larynx

minimum pressure during deglutitive UES relaxation

UES anterior-posterior maximum diameter during swallows

时间窗: After six weeks exerciser regimen, during deglutitive restriction of the larynx

maximum deglutitive diameter in the anterior-posterior direction of the UES measured from fluoroscopic images

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, Director of Clinical and Translational Science Institute, Joseph E. Geenen Professor and Chief of Gastroenterology and Hepatology, Principal Investigator

Medical College of Wisconsin

研究点 (2)

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