High Resolution Manometry for Swallowing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-01-31

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.

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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.

Conditions

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Motility Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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esophageal manometry

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.

Group Type EXPERIMENTAL

esophageal manometry

Intervention Type PROCEDURE

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.

Gatorade

Intervention Type DIETARY_SUPPLEMENT

The patient will be given Gatorade to drink at various times during the study.

Supine position

Intervention Type OTHER

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.

Semi-recumbent position

Intervention Type OTHER

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.

Sitting

Intervention Type PROCEDURE

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.

Standing

Intervention Type PROCEDURE

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.

Interventions

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esophageal manometry

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.

Intervention Type PROCEDURE

Gatorade

The patient will be given Gatorade to drink at various times during the study.

Intervention Type DIETARY_SUPPLEMENT

Supine position

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.

Intervention Type OTHER

Semi-recumbent position

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.

Intervention Type OTHER

Sitting

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.

Intervention Type PROCEDURE

Standing

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.

Intervention Type PROCEDURE

Other Intervention Names

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Semi-recumbent Sitting Standing up Supine position Sitting position Standing up Supine Semi-recumbent Standing Supine position Semi-recumbent position Sitting position

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes