Sonographic Diaphragm Function in AECOPD

Study 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.

Official Title
-----------------
Ultrasound of the Diaphragm as Physiological Biomarker in Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Copd

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasound of the diaphragm


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|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).|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - To investigate the responsiveness of sonographic parameters to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis. | 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 | from admission till hospital discharge (expected median of 5 days based on experience) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diaphragm, COPD, thoracic ultrasound