Trials / Withdrawn
WithdrawnNCT03495219
Can Individuals Control Pressure in Their Esophagus.
Subjects Ability to Control Pressure in the Lower Esophageal High Pressure Znoe (HPZ) During Manometry.
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-06-01
- Primary completion
- 2020-01-02
- Completion
- 2020-03-30
- First posted
- 2018-04-11
- Last updated
- 2019-05-09
Source: ClinicalTrials.gov record NCT03495219. Inclusion in this directory is not an endorsement.