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

Recruitingn/aAges 18 Years - anyAllIsala
NCT07259174 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

3.1 Introduction and rationale In 2020 an estimate of 562.700 people had Chronic Obstructive Pulmonary Disease (COPD) in the Netherlands, resulting in 21.335 hospital admissions.\[1\] An acute exacerbation COPD (AECOPD) in combination with hospital admission is associated with high mortality and morbidity. \[2\] Noninvasive ventilation (NIV) has been very effective in the context of AECOPD, since it efficiently offloads respiratory muscles and counteracts dynamic hyperinflation. This method often prevents intubation as a bridge to administering effective therapies (e.g., glucocorticoids, bronchodilators, and antibiotic agents)\[3\], and may reduce mortality.\[4\] Current guidelines recommend NIV for the treatment of acute respiratory failure in patients with respiratory distress, pH \< 7.35, and PaCO2 \> 6 kPA (with exclusion of patients requiring invasive ventilation, see guideline).\[

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📋 Eligibility rules (as published)
• 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
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What it tests

  • Not listed
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Where

2 sites
Isala
Zwolle, Netherlands
University Medical Centre Groningen
Groningen, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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