High Resolution Manometry for Swallowing (HRM)

University of Florida

Status and phase: Terminated; Phase 1

Conditions: Motility Disorder

Treatments: Other: Semi-recumbent position; Procedure: Standing; Other: Supine position; Procedure: Sitting; Procedure: esophageal manometry; Dietary Supplement: Gatorade

Study type: Interventional

Funder types: Other

Identifiers

NCT01773330

502-2012

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 71 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

esophageal manometry

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Gatorade

Procedure: esophageal manometry

Procedure: Sitting

Other: Supine position

Procedure: Standing

Other: Semi-recumbent position