Ultrasound of the Diaphragm As Physiological Biomarker in Acute Exacerbations of Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Isala
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- - To investigate the responsiveness of sonographic parameters to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
- To investigate the responsiveness of sonographic parameters to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis.
时间窗: 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
次要结局
未报告次要终点