Sonographic Diaphragm Function in AECOPD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound of the diaphragm.
- Who it may be relevant to
- Registry conditions: Copd. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Ultrasound of the Diaphragm As Physiological Biomarker in Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Overview
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.
Interventions
- Diagnostic test Ultrasound of the diaphragm
Sonographic parameters of the diaphragm: * Thickening Fraction (TF); (Diaphragm thickness end-inspiration- Diaphragm thickness end-expiration) / Diaphragm thickness end-expiration. (continuous variable). * Diaphragm end-expiratory thickness: Diaphragm thickness at end-expiration (continuous variable) * Diaphragm excursion (DE): diaphragm inspiratory amplitude during deep breathing (continuous variable).
Primary outcome measures
- - 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)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Isala Klinieken — Zwolle
Identifiers
NCT: NCT05671198 · Diaphragm 002