Assessing diaphragm function in patients with acute COPD exacerbations
Ultrasound of the Diaphragm As Physiological Biomarker in Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Isala · NCT05671198
This study is testing if ultrasound measurements of diaphragm function can help understand how breathing difficulties change in patients hospitalized for acute COPD flare-ups.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 51 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Isala (other) |
| Locations | 1 site (Zwolle, Overijssel) |
| Trial ID | NCT05671198 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate how well ultrasound measurements of diaphragm function can reflect changes in dyspnea levels, as measured by the Borg score, in patients hospitalized for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) without respiratory acidosis. Participants will undergo ultrasound assessments of diaphragm parameters such as excursion and thickness within 48 hours of admission, with follow-up assessments conducted prior to discharge. The study will utilize validated questionnaires to gauge dyspnea levels alongside ultrasound evaluations.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients experiencing severe acute exacerbations of COPD without respiratory acidosis.
Not a fit: Patients with respiratory acidosis or those requiring invasive ventilation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of dyspnea in COPD patients by providing a non-invasive method to assess diaphragm function.
How similar studies have performed: While the use of ultrasound for diaphragm assessment is established, this specific application in AECOPD without respiratory acidosis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Hospitalisation primarily because of severe acute exacerbation of COPD * COPD, according to GOLD 2018 definition * Post-bronchodilator FEV1/FVC \< 0,70 and FEV1% \< 80%pred. within last 5 years Exclusion Criteria: * Respiratory acidosis (pH \< 7.35 ánd PaCO2 \> 6 kPA) * Need for (non-)invasive ventilation based on other criteria (e.g. severe hypoxia) upon presentation. * 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
- Isala Klinieken — Zwolle, Overijssel, Netherlands (RECRUITING)
Study contacts
- Study coordinator: wytze s de Boer, m.d.
- Email: w.s.de.boer@isala.nl
- Phone: 00316463120231
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Copd, diaphragm, COPD, thoracic ultrasound