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Correlation of Diaphragm Shear-Wave Elastography With Transdiaphragmatic Pressure in Healthy Adults: a Feasibility Study

NCT07253480 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2025-12-05

No results posted yet for this study

Summary

Changes in intrapleural pressure after lung volume reduction in Chronic Obstructive Pulmonary disease (COPD) patients can lead to complications, including an increased risk of pneumothorax. This procedure, intended to improve lung function, may disturb the pressure balance within the pleural space, potentially precipitating pneumothorax. Careful monitoring of intrapleural pressure could help predict patients at risk. However, intrapleural pressure can currently only be measured invasively. Diaphragm shear-wave elastography (SWE) has been shown to reflect transdiaphragmatic pressure during isovolumetric inspiratory efforts and ventilation against inspiratory loading, and therefore may serve as a non-invasive surrogate for intrapleural pressure. This project outlines a stepwise study plan to evaluate SWE as a tool for intrapleural pressure monitoring (Figure 1). The project only moves to the next phase is the study previous phase was achieved successfully. The current protocol involves the first phase: to validate diaphragm SWE against transdiaphragmatic pressure and assess measurement reliability for local ultrasound systems in healthy adults.This prospective, single-centre, observational validation study will include twelve healthy adult volunteers. During a single study session, participants will perform standardized inspiratory efforts while simultaneous measurements of diaphragm SWE, transdiaphragmatic pressure (via esophageal and gastric balloon catheters), and mouth pressures are obtained. These methods are routinely applied in physiological research and carry minimal risk. Apart from brief nasal or throat discomfort during catheter placement, no significant adverse effects are expected. By establishing the relationship between diaphragm SWE, transdiaphragmatic pressure, and mouth pressures, this study aims to provide the essential validation step for future clinical research in COPD patients following lung volume reduction.

Conditions

  • Diaphragm Ultrasound
  • Diaphragm Dysfunction
  • Health Adult Subjects

Interventions

DIAGNOSTIC_TEST

shear wave elastography of the diaphragm

Participants will undergo simultaneous measurements of diaphragm SWE, transdiaphragmatic pressure (Pdi = Pga-Pes), and inspiratory mouth pressures (Pmo) at rest and during inspiratory efforts at 20%, 40%, and 60% of PImax. SWE will be performed twice by different operators to assess inter-rater reliability. The primary analysis will determine within-individual and overall correlations between SWE and Pdi. \- Pearson correlation coefficient repeated-measures correlation coefficient between SWE and Pdi across inspiratory efforts.

Sponsors & Collaborators

  • University Medical Center Groningen

    collaborator OTHER

  • Isala

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-06-30
Completion
2026-09-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07253480 on ClinicalTrials.gov