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Can Individuals Control Pressure in Their Esophagus.

Subjects Ability to Control Pressure in the Lower Esophageal High Pressure Znoe (HPZ) During Manometry.

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03495219
Acronym
manometry
Enrollment
0
Registered
2018-04-11
Start date
2019-06-01
Completion date
2020-03-30
Last updated
2019-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux

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.

Interventions

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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Association of RSI to resting manometry pressure in the lower esophagus1 dayAt 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 dayVerbal, tactile coaching on diaphragm recruitment will be given while under manometry to establish the ability of subjects to improve lower esophageal pressure.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026