Dysphagia
Conditions
Keywords
pharyngeal pressure events, swallowing, measurement, diagnosis
Brief summary
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.
Detailed description
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.
Interventions
DEVICELaborie LMT Pharyngeal System (3.7 mm catheter)
The Solar GI HRM system is intended to record, store, view, and analyze pressure, impedance, EMG, swallow and respiration, and various auxiliary input device data online anywhere in the gastrointestinal tract (pharynx; esophagus; stomach; duodenum; sphincter of Oddi; small bowel; colon and anorectal area, including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Used with 3.7 mm catheter.
DEVICEMedtronic ManoScan ESO HRM System (4.2 mm catheter)
The ManoScan™ ESO high resolution manometry system enables full evaluation of the motor functions of the esophagus. The system provides useful information to support diagnosis of conditions like dysphagia, achalasia, and hiatal hernia. A 36-channel circumferential solid-state catheter with 4.2 mm diameter, 1.0 cm spacing between adjacent sensors.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Each participant will complete two HRM procedures in a randomized cross-over design with a 1:1 allocation to determine the order of catheter use
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* without known swallowing disorders
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contractile front velocity | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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 | data collected during 1 study visit (up to 2 hours) | Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison. |
| Base of tongue pressure | 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 | 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 | 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. |
Countries
United States
Contacts
CONTACTSuzan Abdelhalim, MD
PRINCIPAL_INVESTIGATORTimothy McCulloch, MD
University of Wisconsin, Madison
Outcome results
None listed