Can Individuals Control Pressure in Their Esophagus. (manometry)
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|ClinicalTrials.gov Identifier: NCT03495219|
Recruitment Status : Withdrawn (Unable to use manometry lab.)
First Posted : April 11, 2018
Last Update Posted : May 9, 2019
|Condition or disease||Intervention/treatment|
|Gastroesophageal Reflux||Procedure: Esophageal Manometry|
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 Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Subjects Ability to Control Pressure in the Lower Esophageal High Pressure Znoe (HPZ) During Manometry.|
|Estimated Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||January 2, 2020|
|Estimated Study Completion Date :||March 30, 2020|
Esophageal manometry is a test to assess motor function of the upper esophageal sphincter, esophageal body and lower esophageal sphincter
Procedure: Esophageal Manometry
A catheter inserted through the nares, post appropriate anesthetization. The subject is then given 8 - 10 sips of water or semi viscous fluid during the routine study. At the conclusion of the clinical portion of the examination the manometer catheter is typically removed by the technician at that point. For the purposes of this research study the catheter will remain in place to examine pressures specifically at the lower end of the esophagus during various breathing patterns and training activities to see if pressures can be increased with instruction.
- Reduction in Reflux Symptom Index Score (RSI) [ Time Frame: 3 months. ]Does intervention reduce RSI score from before intervention to follow up.
- Association of RSI to resting manometry pressure in the lower esophagus [ Time Frame: 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. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495219
|Principal Investigator:||C J Yelvington||Mayo Clinic|