Establishing Pressures at the EGJ During Diaphragmatic Breathing Using High-resolution Esophageal Manometry

March 24, 2024 updated by: Andree H. Koop, Mayo Clinic

Establishing Pressures at the Esophagogastric Junction During Diaphragmatic Breathing Using High-resolution Esophageal Manometry

The goal of this study is to determine which position, maneuvers or combination thereof generates the highest pressure at the EGJ as assessed by high-resolution esophageal manometry and thus greater or more robust contraction of the diaphragm.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single-center study of adult (age ≥18 years) participants undergoing high-resolution esophageal manometry to assess the optimal method of diaphragmatic breathing. Included patients will complete two validated surveys, the Brief Esophageal Dysphagia Questionnaire (BEDQ) and the Gastroesophageal Reflux Disease Questionnaire (GERDQ). Patients will then undergo a standard protocol of supine and upright swallows with high-resolution manometry analyzed according to the Chicago Classification v4.0. After completion of the standard manometry protocol, participants will then perform a protocol assessing different techniques and positions for diaphragmatic breathing.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • patients undergoing high-resolution esophageal manometry

Exclusion Criteria:

  • prior esophageal or gastric surgery
  • chest tube
  • major concomitant illness
  • sinus disease precluding manometry placement
  • history of heavy alcohol or tobacco use
  • poor comprehension and/or fluency of English language
  • inability or unwillingness of individual to give written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Diaphragmatic breathing protocol
All patients will undergo the diaphragmatic breathing protocol with high-resolution esophageal manometry.
Diagnostic test: diaphragmatic breathing
Different positions and techniques for diaphragmatic breathing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure at the esophagogastric junction
Time Frame: Measured for each participant during high-resolution esophageal manometry. Data will be collected over the enrollment period of one year.
Measurement of EGJ- contractile integral and diaphragmatic pressure with each exercise/instruction
Measured for each participant during high-resolution esophageal manometry. Data will be collected over the enrollment period of one year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Andree Koop, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 24, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 24, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-012635

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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