Shear-wave Elastography Compared to Respiratory Function Testing

December 19, 2023 updated by: Carlos B Mantilla, MD, PhD, Mayo Clinic

Comparison of Shear-wave Elastography to State-of-the-art Respiratory Function Testing to Measure the Range of Forces Generated by the Diaphragm Muscle

The purpose of this study is to evaluate the relationship between transdiaphragmatic pressure (Pdi) and diaphragm shear-wave elastography (SWE) during state-of-the-art respiratory muscle testing including volitional efforts (e.g., maximal inspiratory pressure, maximal expiratory pressure, Valsalva maneuver), as well as maximal phrenic nerve stimulation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- Adult male and female healthy volunteers.

Exclusion Criteria:

  • Volunteers who are pregnant.
  • Volunteers with known pulmonary pathology (COPD, asthma requiring routine treatment).

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Respiratory Function Testing
All subjects will receive standard respiratory function testing and ultrasound-based elastography measurements across various behaviors and conditions
Diagnostic test: Shear-wave elastography
Ultrasound based imaging of diaphragm muscle activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shear wave speed
Time Frame: 3 hours
Elastography of the diaphragm muscle across various behaviors and conditions
3 hours

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Carlos Matilla, MD, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

July 28, 2021

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

July 2, 2021

First Submitted That Met QC Criteria

July 2, 2021

First Posted (Actual)

July 13, 2021

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 21-003003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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