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Search / Trial NCT05671198

Sonographic Diaphragm Function in AECOPD

Launched by ISALA · Dec 20, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Diaphragm Copd Thoracic Ultrasound

ClinConnect Summary

This clinical trial is studying how well ultrasound can measure diaphragm function in patients with a severe flare-up of Chronic Obstructive Pulmonary Disease (COPD) who are hospitalized. The main goal is to see if changes in diaphragm activity can help understand how much trouble a patient is having with breathing, as measured by a simple scale called the Borg score, during their hospital stay.

To join the study, participants need to be hospitalized due to a serious COPD exacerbation and meet specific criteria, including having certain lung function test results. The trial is open to adults aged 65 to 74, regardless of gender. Participants will have their diaphragm assessed using ultrasound, which is a painless imaging technique, and will provide information that might help doctors better manage breathing difficulties in the future. It’s important to note that patients with certain conditions, like severe respiratory problems or those who are pregnant, cannot participate. If you meet the criteria and are interested, you can discuss this opportunity with your healthcare provider.

Gender

ALL

Eligibility 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

About Isala

Isala is a leading healthcare organization based in the Netherlands, renowned for its commitment to advancing medical research and improving patient care through innovative clinical trials. With a strong focus on collaboration and multidisciplinary approaches, Isala integrates clinical expertise and cutting-edge technology to develop and evaluate new treatments across various therapeutic areas. The organization prioritizes patient safety and ethical standards, ensuring that all research initiatives are conducted with the highest level of integrity. Through its dedication to scientific excellence and patient outcomes, Isala strives to contribute significantly to the global medical community.

Locations

Zwolle, , Netherlands

Zwolle, Overijssel, Netherlands

Patients applied

0 patients applied

Trial Officials

Marieke Duiverman, M.D. PhD.

Study Director

UMCG

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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