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Can Individuals Control Pressure in Their Esophagus. (manometry)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495219
Recruitment Status : Withdrawn (Unable to use manometry lab.)
First Posted : April 11, 2018
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
C. Joseph Yelvington P.T., D.P.T., 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.

Condition or disease Intervention/treatment
Gastroesophageal Reflux Procedure: Esophageal Manometry

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Group/Cohort Intervention/treatment
Esophageal Manometry
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.




Primary Outcome Measures :
  1. Reduction in Reflux Symptom Index Score (RSI) [ Time Frame: 3 months. ]
    Does intervention reduce RSI score from before intervention to follow up.


Secondary Outcome Measures :
  1. 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?

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults undergoing outpatient ambulatory procedures at Mayo Clinic Jacksonville.
Criteria

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.


Information from the National Library of Medicine

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


Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: C J Yelvington Mayo Clinic
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: C. Joseph Yelvington P.T., D.P.T., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03495219    
Other Study ID Numbers: 17-003796
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: What may be released include: study protocol, statistical analysis, clinical study report. Should this want to be replicated at other Mayo sites.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases