Shear-wave Elastography Compared to Respiratory Function Testing

Not Applicable

Recruiting

• Conditions: Respiratory Complication; Respiratory Function Loss
• Interventions: Diagnostic Test: Shear-wave elastography

• Registration Number: NCT04959526
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-02
• Study First Posted: 2021-07-13
• Study Start: 2021-07-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Adult male and female healthy volunteers.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Respiratory Function Testing	Shear-wave elastography	All subjects will receive standard respiratory function testing and ultrasound-based elastography measurements across various behaviors and conditions

Primary Outcome Measures

Name	Time	Method
Shear wave speed	3 hours	Elastography of the diaphragm muscle across various behaviors and conditions

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States