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

NCT07253480 | Not Yet Recruiting

• 1 other identifier: PLEASSURE 1
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

diaphragm; ultrasound; diaphragmatic pressure; shear-wave elastography

Outcome Measures

Primary Outcomes (1)

• - Pearson correlation coefficient repeated-measures correlation coefficient between SWE and Pdi across inspiratory efforts.

  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.

  1 hour

Study Arms (1)

healthy adults

prospective validation cohort of healthy adults

Diagnostic Test: shear wave elastography of the diaphragm

Interventions

shear wave elastography of the diaphragm DIAGNOSTIC_TEST

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.

healthy adults

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy adults.

You may qualify if:

• years, BMI 18-30 kg/m²
• No known respiratory, neuromuscular, or cardiothoracic disease
• Able to perform inspiratory maneuvers and consent.

You may not qualify if:

• Pregnancy
• History of smoking (\> 10 pack years)
• Impaired swallowing, as well as esophageal diseases, or disorders at the level of the gastroesophageal sphincter

Sponsors & Collaborators

• Isala: lead
• University Medical Center Groningen: collaborator

Study Sites (1)

University Medical Centre Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

Location

Central Study Contacts

Wytze S de Boer, MD

CONTACT

(+31)0646312031; w.s.de.boer@isala.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

NL (1)