Pharyngeal High Resolution Manometry Standardization of Metrics
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Base of tongue pressure
研究概览
简要总结
This study aims to directly compare and contrast swallowing pressure and impedance measurements obtained from two high-resolution manometry (HRM) systems: the Laborie LMT Pharyngeal System and the Medtronic ManoScan ESO HRM System in healthy adult volunteers. The primary objective is to determine how differences in catheter diameter, sensor configuration, and acquisition platforms influence measurement outcomes. Twenty-five healthy adults will participate in a single, approximately 2-hour visit; the study will be open for one year for data collection and two years for data analysis.
详细描述
The primary objective is to obtain, compare, and contrast directly the measured swallow between the Laborie Pharyngeal HRM impedance system with the 3.7 mm catheter and the Medtronic HRM impedance system with the 4.2 mm catheter in the same setting with normal healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •without known swallowing disorders
排除标准
- •Known swallowing disorder
- •Allergy to topical anesthetic
- •Allergy to food relevant to study participation (e.g. lactose intolerance)
- •Inability to follow direction or remain calm during the experiment.
研究组 & 干预措施
Medtronic then Laborie
This study will include a data collection session that involves swallowing tasks during HRM.
干预措施: Medtronic ManoScan ESO HRM System (4.2 mm catheter) (Device)
Medtronic then Laborie
This study will include a data collection session that involves swallowing tasks during HRM.
干预措施: Laborie LMT Pharyngeal System (3.7 mm catheter) (Device)
Laborie then Medtronic
This study will include a data collection session that involves swallowing tasks during HRM.
干预措施: Laborie LMT Pharyngeal System (3.7 mm catheter) (Device)
Laborie then Medtronic
This study will include a data collection session that involves swallowing tasks during HRM.
干预措施: Medtronic ManoScan ESO HRM System (4.2 mm catheter) (Device)
结局指标
主要结局
Base of tongue pressure
时间窗: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Hypopharyngeal peak pressure
时间窗: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Pharyngeal Contractile Integral (PhCI)
时间窗: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Pressure rise time
时间窗: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Contractile front velocity
时间窗: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Upper Esophageal Sphincter (UES) resting pressure
时间窗: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
UES peak contraction pressure
时间窗: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
UES relaxation nadir pressure
时间窗: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
UES relaxation duration
时间窗: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Nadir impedance
时间窗: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Bolus presence time
时间窗: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Flow interval
时间窗: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Pressure-flow index component
时间窗: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Timing relationships (onset-to-peak intervals)
时间窗: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Construction of Spatial pressure distribution maps
时间窗: data collected during 1 study visit (up to 2 hours)
Multi-level modeling for repeated measures across bolus types, volumes, and repetitions. Sensor-level and region-level analyses (BOT, hypopharynx, UES). Agreement thresholds and bias definitions added to facilitate interpretability and ensure clarity for cross-platform comparison. Map layers will be summarized as a proxy for this measure.
次要结局
未报告次要终点