NCT04959526

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Jul 2021Dec 2026

First Submitted

Initial submission to the registry

July 2, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

July 28, 2021

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

5.3 years

First QC Date

July 2, 2021

Last Update Submit

March 12, 2026

Conditions

Respiratory Function LossRespiratory Complication

Keywords

ElastographyUltrasound

Outcome Measures

Primary Outcomes (1)

  • Shear wave speed

    Elastography of the diaphragm muscle across various behaviors and conditions

    3 hours

Study Arms (1)

Respiratory Function Testing

EXPERIMENTAL

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

Diagnostic Test: Shear-wave elastography

Interventions

Shear-wave elastographyDIAGNOSTIC_TEST

Ultrasound based imaging of diaphragm muscle activity

Respiratory Function Testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Adult male and female healthy volunteers.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Study Officials

  • Carlos Matilla, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 2, 2021

First Posted

July 13, 2021

Study Start

July 28, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations

US(1)