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Clinical Trials/NCT05671198
NCT05671198
Recruiting
Not Applicable

Ultrasound of the Diaphragm As Physiological Biomarker in Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Isala1 site in 1 country51 target enrollmentMarch 27, 2023
ConditionsCopd

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Copd
Sponsor
Isala
Enrollment
51
Locations
1
Primary Endpoint
- To investigate the responsiveness of sonographic parameters to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis.
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The study will be conducted as a single-center, prospective cohort study. The primary objective of this study is to investigate the responsiveness of sonographic parameters of diaphragm to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis.

Detailed Description

To investigate the responsiveness of sonographic parameters to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis, we propose a prospective cohort design. After inclusion, participants will have assessment of diaphragm function (excursion, thickness, thickening fraction) using ultrasound within 48 hours of admission to the emergency ward, striving to assessment within 24 hours of admission. Additionally, dyspnea grade will be assessed using validated questionnaires. Further diagnostic work-up and treatment for AECOPD is performed at the discretion of the treating physician. Both ultrasound measurements and dyspnea grade questionnaires will be repeated when the participant is reported suitable for hospital discharge by the treating physician.

Registry
clinicaltrials.gov
Start Date
March 27, 2023
End Date
August 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Isala
Responsible Party
Principal Investigator
Principal Investigator

Wytze de Boer

Coördinating Investigator

Isala

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

Outcomes

Primary Outcomes

- To investigate the responsiveness of sonographic parameters to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis.

Time Frame: from admission till hospital discharge (expected median of 5 days based on experience)

Correlation between: * Change in Borg score for dyspnea; defined as score at discharge minus score at admission * Change in sonographic parameters; defined as score at discharge minus score at admission

Study Sites (1)

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