Can Individuals Control Pressure in Their Esophagus.

NCT03495219 | Withdrawn

• 1 other identifier: 17-003796
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

• Reduction in Reflux Symptom Index Score (RSI)

  Does intervention reduce RSI score from before intervention to follow up.

  3 months.

Secondary Outcomes (2)

• Association of RSI to resting manometry pressure in the lower esophagus

  1 day

• Can lower esophageal pressure can be increased by instruction/coaching by a physical therapist.

  1 day

Study Arms (1)

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

Interventions

Esophageal Manometry PROCEDURE

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.

Esophageal Manometry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing outpatient ambulatory procedures at Mayo Clinic Jacksonville.

You may qualify if:

• Eligibility is forwarded to all individuals undergoing routine esophageal manometry. They would have had to have met all eligibility criteria for this procedure.

Sponsors & Collaborators

• Mayo Clinic: lead

Related Publications (3)

• 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.

  PMID: 12905637 BACKGROUND

• 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.

  PMID: 24405544 BACKGROUND

• Eherer AJ, Netolitzky F, Hogenauer 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 Mar;107(3):372-8. doi: 10.1038/ajg.2011.420. Epub 2011 Dec 6.

  PMID: 22146488 RESULT

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• C J Yelvington

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 11, 2018
• Study Start: June 1, 2019
• Primary Completion: January 2, 2020
• Study Completion: March 30, 2020
• Last Updated: May 9, 2019

Record last verified: 2019-05