High Resolution Manometry for Swallowing

Phase 1

Terminated

• Conditions: Motility Disorder
• Interventions: Procedure: esophageal manometry; Dietary Supplement: Gatorade; Other: Supine position; Other: Semi-recumbent position; Procedure: Sitting; Procedure: Standing

• Registration Number: NCT01773330
• Lead Sponsor: University of Florida

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-01-11
• Study First Submitted QC: 2013-01-17
• Study First Posted: 2013-01-23
• Study Start: 2013-10
• Status Verified: 2015-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-21
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 71

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
esophageal manometry	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.
esophageal manometry	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.
esophageal manometry	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.
esophageal manometry	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.
esophageal manometry	Gatorade	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.
esophageal manometry	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.

Primary Outcome Measures

Name	Time	Method
Normal values for HRM while the patient is in the most physiologic position to stimulate normal eating habits.	up to 1 hour	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.

Secondary Outcome Measures

Name	Time	Method
Normal HRM values for a 200 ml provocative swallow.	up to 5 minutes	The patient is instructed to swallow 200 ml of Gatorade in the sitting position.
Bolus clearance for each swallow with impedance.	up to 1 hour	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.
Normal size and diameter of esophagus and esophageal distension on a regular basis with the provocative swallow and impedance.	up to 1 hour	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.
Standardization of the testing protocol for HRM and the reliability of volume and number of swallows.	up to 1 hour	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.

Trial Locations

Locations (1)

Shands Endoscopy Center; 🇺🇸 Gainesville, Florida, United States