Can Individuals Control Pressure in Their Esophagus.

Gastroesophageal Reflux Clinical Trial

— manometry  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03495219
• Other study ID #: 17-003796
• Status: Withdrawn
• Start date: June 1, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: May 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 30, 2020
• Est. primary completion date: January 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

References & Publications (3)

Ding ZL, Wang ZF, Sun XH, Ke MY. [Therapeutic mechanism of diaphragm training at different periods in patients with gastroesophageal reflux disease]. Zhonghua Yi Xue Za Zhi. 2013 Oct 29;93(40):3215-9. Chinese. — View Citation

Eherer AJ, Netolitzky F, Högenauer C, Puschnig G, Hinterleitner TA, Scheidl S, Kraxner W, Krejs GJ, Hoffmann KM. Positive effect of abdominal breathing exercise on gastroesophageal reflux disease: a randomized, controlled study. Am J Gastroenterol. 2012 M — View Citation

Sun XH, Ke MY, Wang ZF, Fang XC. [Roles of diaphragmatic crural barrier and esophageal body clearance in patients with gastroesophageal reflux disease]. Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2002 Jun;24(3):289-93. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Reflux Symptom Index Score (RSI)	Does intervention reduce RSI score from before intervention to follow up.	3 months.
Secondary	Association of RSI to resting manometry pressure in the lower esophagus	At rest, is basal esophageal pressure associated with subjects RSI scores?	1 day
Secondary	Can lower esophageal pressure can be increased by instruction/coaching by a physical therapist.	Verbal, tactile coaching on diaphragm recruitment will be given while under manometry to establish the ability of subjects to improve lower esophageal pressure.	1 day

External Links

•   Mayo Clinic Clinical Trials