High Resolution Manometry: Optimizing the Swallow Protocol
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Motility Disorder
- Sponsor
- University of Florida
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Normal values for HRM while the patient is in the most physiologic position to stimulate normal eating habits.
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Normal values for HRM while the patient is in the most physiologic position to stimulate normal eating habits.
Time Frame: 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 Outcomes
- Normal HRM values for a 200 ml provocative swallow.(up to 5 minutes)
- Bolus clearance for each swallow with impedance.(up to 1 hour)
- Normal size and diameter of esophagus and esophageal distension on a regular basis with the provocative swallow and impedance.(up to 1 hour)
- Standardization of the testing protocol for HRM and the reliability of volume and number of swallows.(up to 1 hour)