Sonographic Diaphragm Function in AECOPD
ConditionCopd
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIsala
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial population
Our population consists of 18-years or older patients who are hospitalised primarily due to AECOPD without respiratory acidosis.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ultrasound of the diaphragm
Diagnostic testSonographic 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).
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
- 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
Time frame
from admission till hospital discharge (expected median of 5 days based on experience) Source ClinicalTrials.gov