High Resolution Manometry for Swallowing

Study Overview
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Brief Summary
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This study is using a new technology known as high resolution manometry which is used to evaluate patients that have trouble swallowing or have chest pain that is not related to the heart. The investigator wants to learn how the different positions of the body, in a lying position, semi-recumbent, sitting position or standing up, and the amount of liquid affects the outcome of the test. This will help the investigator to determine a standardized protocol for patients with trouble swallowing.

Detailed Description
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The esophageal manometry will be performed in the motility lab at the Shands Endoscopy Center by passing a small tube into the patients nose, down the food pipe and into the stomach. The participants will be instructed to swallow a determined volume of Gatorade,depending on the protocol being followed. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up. When the esophageal manometry is finished, the tube is removed and participation in this study is complete.

Official Title
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High Resolution Manometry: Optimizing the Swallow Protocol

Conditions
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Motility Disorder

Intervention / Treatment
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* Procedure: esophageal manometry
* Dietary Supplement: Gatorade
* Other: Supine position
* Other: Semi-recumbent position
* Procedure: Sitting
* Procedure: Standing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 Healthy Volunteer No clinical evidence of dysphagia Exclusion Criteria: History of prior dysphagia Prior esophageal or gastric dysmotility secondary to systemic conditions (scleroderma or diabetes mellitus) Known gastrointestinal malignancy Use of medications known to affect esophageal or gastric motility (e.g. anticholinergics, opiates, calcium channel blockers) Previous esophageal or gastric surgery Significant cardiac or respiratory disease Pregnancy (a pregnancy test will be performed in women of child-bearing potential)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: esophageal manometry<br>Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position. | Procedure: esophageal manometry<br>* Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed.There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.<br>Dietary Supplement: Gatorade<br>* The patient will be given Gatorade to drink at various times during the study.<br>Other: Supine position<br>* Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.<br>* Other names: Standing up;Other: Semi-recumbent position<br>* Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.<br>* Other names: Standing up;Procedure: Sitting<br>* Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.<br>* Other names: Standing;Procedure: Standing<br>* Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.<br>* Other names: Sitting position;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal values for HRM while the patient is in the most physiologic position to stimulate normal eating habits. | The patient is instructed to swallow a determined volume of Gatorade. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up. | up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal HRM values for a 200 ml provocative swallow. | The patient is instructed to swallow 200 ml of Gatorade in the sitting position. | up to 5 minutes | 
| Bolus clearance for each swallow with impedance. | The patient is instructed to swallow a determined volume of Gatorade. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up. | up to 1 hour | 
| Normal size and diameter of esophagus and esophageal distension on a regular basis with the provocative swallow and impedance. | The patient is instructed to swallow different amounts of Gatorade. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up. | up to 1 hour | 
| Standardization of the testing protocol for HRM and the reliability of volume and number of swallows. | The patient is instructed to swallow different amounts of Gatorade. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up. | up to 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high resolution manometry, provocative swallow, impedence