Respiratory Complication Clinical Trial
Official title:
Comparison of Shear-wave Elastography to State-of-the-art Respiratory Function Testing to Measure the Range of Forces Generated by the Diaphragm Muscle
| NCT number | NCT04959526 |
| Other study ID # | 21-003003 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 28, 2021 |
| Est. completion date | June 2024 |
| Verified date | December 2023 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 24 |
| Est. completion date | June 2024 |
| Est. primary completion date | June 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Adult male and female healthy volunteers. Exclusion Criteria: - Volunteers who are pregnant. - Volunteers with known pulmonary pathology (COPD, asthma requiring routine treatment). |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic in Rochester | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Shear wave speed | Elastography of the diaphragm muscle across various behaviors and conditions | 3 hours |
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