Bedside diaphragm ultrasound to measure breathing-muscle movement during COPD flare-ups

Ultrasound of the Diaphragm Excursion Ratio as Physiological Biomarker in Acute Exacerbations of Chronic Obstructive Pulmonary Disease

This project tests whether a quick bedside ultrasound measurement of diaphragm movement can help doctors understand breathing problems in people hospitalized with severe COPD flare-ups.

Quick facts

• Study type: Observational
• Enrollment: 186 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Isala (Academic / other)
• Locations: 2 sites (Zwolle, Overijssel and 1 other locations)
• Trial ID: NCT07259174 on ClinicalTrials.gov

What this trial studies

This observational study will use bedside ultrasound to measure the diaphragm excursion ratio in patients hospitalized for severe acute exacerbations of COPD. Eligible patients must have prior spirometry confirming COPD (post-bronchodilator FEV1/FVC < 0.70 and FEV1 < 80% predicted) and at least 10 pack-years of smoking; patients who are mechanically ventilated, have known diaphragm paralysis, are pregnant, or cannot cooperate will be excluded. Ultrasound measurements will be collected during hospitalization and compared with clinical data such as blood gases, respiratory support needs (including noninvasive ventilation), and short-term outcomes. The study is conducted at Isala (Zwolle) and University Medical Center Groningen (Groningen) in the Netherlands.

Who should consider this trial

Good fit: People hospitalized primarily for severe AECOPD with prior spirometry showing FEV1/FVC < 0.70 and FEV1 < 80% predicted, at least 10 pack-years, and the ability to give informed consent and cooperate with ultrasound imaging.

Not a fit: Patients already on invasive mechanical ventilation, with known diaphragm paralysis, who cannot follow vocal instructions, or who cannot give informed consent (including pregnant women excluded from participation) are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could provide clinicians a quick, noninvasive test to identify patients at higher risk of respiratory failure and help guide decisions about respiratory support.

How similar studies have performed: Previous smaller studies have shown diaphragm ultrasound can reflect respiratory muscle function and sometimes predict outcomes in acute respiratory failure, but using the diaphragm excursion ratio specifically as a biomarker in AECOPD remains relatively untested.

Eligibility criteria

• Inclusion criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* Hospitalization primarily because of severe acute exacerbation of COPD
* Spirometry record within last 5 years, with: post-bronchodilator FEV1/FVC \< 0,70 and FEV1% \< 80%predicted
* Minimum of 10 packyears

  * Exclusion criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Established diagnosis of diaphragm diaphragm paralysis.
* Inability for diaphragm imaging (e.g. mechanical ventilation, or unable to follow vocal instructions).
* Those not able or unwilling to give written informed consent.
* Pregnant women

Where this trial is running

Zwolle, Overijssel and 1 other locations

• Isala — Zwolle, Overijssel, Netherlands (Recruiting)
• University Medical Centre Groningen — Groningen, Provincie Groningen, Netherlands (Recruiting)

Study contacts

• Study coordinator: Wytze S de Boer, MD

Conditions COPD; diaphragm; ultrasound