Shear-wave Elastography Compared to Respiratory Function Testing

NCT ID: NCT04959526

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-28

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Function Loss Respiratory Complication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Respiratory Function Testing

All subjects will receive standard respiratory function testing and ultrasound-based elastography measurements across various behaviors and conditions

Group Type EXPERIMENTAL

Shear-wave elastography

Intervention Type DIAGNOSTIC_TEST

Ultrasound based imaging of diaphragm muscle activity

Interventions

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Shear-wave elastography

Ultrasound based imaging of diaphragm muscle activity

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

\- Adult male and female healthy volunteers.

Exclusion Criteria

* Volunteers who are pregnant.
* Volunteers with known pulmonary pathology (COPD, asthma requiring routine treatment).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Carlos B Mantilla, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos Matilla, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Carlos B Mantilla

Role: primary

507-255-1612

Other Identifiers

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21-003003

Identifier Type: -

Identifier Source: org_study_id

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