High Resolution Manometry for Swallowing

Motility Disorder Clinical Trial

— HRM  

Official title:

High Resolution Manometry: Optimizing the Swallow Protocol

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01773330
• Other study ID #: 502-2012
• Status: Terminated
• Phase: Phase 1
• First received: January 11, 2013
• Last updated: January 21, 2015
• Start date: October 2013
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Motility Disorder

Intervention

Procedure:
• 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.

Dietary Supplement:
• Gatorade
The patient will be given Gatorade to drink at various times during the study.

Other:
• 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.
• 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.

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Shands Endoscopy Center	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No