Can Individuals Control Pressure in Their Esophagus.

Withdrawn

• Conditions: Gastroesophageal Reflux
• Interventions: Procedure: Esophageal Manometry

• Registration Number: NCT03495219
• Lead Sponsor: Mayo Clinic

Brief Summary

To establish to what degree individuals can increase esophageal high pressure zone (HPZ) after instruction in deep breathing as evidenced by concurrent manometric pressure readings.

Detailed Description

Pressure in the lower esophagus has been negatively associated with reflux symptoms: the lower the pressure, the more reflux symptoms. This pressure can be augmented with deep abdominal breathing. This can be detected during esophageal manometry, when a pressure catheter is placed into the esophagus. Manometry is routinely done for swallowing disorders.

This study will take place just after a routine manometry test, when the subject still has the catheter in place. All that is required for the research portion is to observe manometry readings while they breathe, then when they deep breath, then breathe after they have been cued or coached to deep abdominal breathing. This is done in sequence to establish how quickly this pressure can be improved.

This coached breathing is then prescribed as a routine exercise and long term follow up performed via phone to see how their reflux symptoms have responded.

Study Timeline

• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-11
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-07
• Last Update Posted: 2019-05-09
• Study Start: 2019-06-01
• Primary Completion: 2020-01-02
• Study Completion: 2020-03-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Eligibility is forwarded to all individuals undergoing routine esophageal manometry. They would have had to have met all eligibility criteria for this procedure.

Exclusion criteria:

-Individuals undergoing modified barium swallow studies (MBSS). Exclusion from MBSS would preclude inclusion in this study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Esophageal Manometry	Esophageal Manometry	Esophageal manometry is a test to assess motor function of the upper esophageal sphincter, esophageal body and lower esophageal sphincter

Primary Outcome Measures

Name	Time	Method
Reduction in Reflux Symptom Index Score (RSI)	3 months.	Does intervention reduce RSI score from before intervention to follow up.

Secondary Outcome Measures

Name	Time	Method
Association of RSI to resting manometry pressure in the lower esophagus	1 day	At rest, is basal esophageal pressure associated with subjects RSI scores?
Can lower esophageal pressure can be increased by instruction/coaching by a physical therapist.	1 day	Verbal, tactile coaching on diaphragm recruitment will be given while under manometry to establish the ability of subjects to improve lower esophageal pressure.