Echographic Characteristics of DIaphragm and FEmoral Quadriceps in COPD Patients: Evaluation of Their Relationship With the Lung Function Impairment and the Effect of Pulmonary Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Variations of diaphragmatic and vastus lateralis muscle function, assessed by US, after 4 weeks of in-hospital Pulmonary Rehabilitation
研究概览
简要总结
The purpose of this study is to evaluate the prognostic role of echographic diaphragmatic assessment and vastus lateralis muscle ultrasound (US) in two independent populations of patients hospitalized for exacerbated Chronic Obstructive Pulmonary Disease (COPD) or undergoing pulmonary rehabilitation.
Specific aims of this protocol are: 1) to analyze the correlation between qualitative and quantitative US parameters and severity of illness indicators and respiratory function data; 2) to detect the postrehabilitation outcomes in terms of diaphragmatic and vastus lateralis muscle function, assessed by US, and the correlation between these outcomes and indicators of pulmonary rehabilitation treatment effectiveness; 3) to evaluate the ability of qualitative and quantitative US parameters to predict in-hospital mortality and length of stay; 4) to evaluate the ability of qualitative and quantitative US parameters to predict exacerbation rate, hospitalization rate and mortality rate six months after the discharge.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Pleural effusion extended for more than two intercostal spaces
- •Interstitial lung diseases
- •Major surgery in the previous 30 days
- •Right pleurodesis or fibrothorax
- •Right stroke outcomes
- •Technical impossibility to perform ultrasound evaluations
- •conditions, clinical or otherwise, that in the investigator's judgment may interfere with the study, or not recommending participation for security reasons
- •Absence of written informed consent
- •Inclusion Criteria (Group B):
- •COPD diagnosis
- •previous or actual cigarette smoking history
- •COPD exacerbation requiring hospitalization in the previous 30 days
- •Indication to undergo a pulmonary rehabilitation protocol
- •Obtained written informed consent
- •Exclusion Criteria:
- •Pleural effusion extended for more than two intercostal spaces
- •Interstitial lung diseases
- •Major surgery in the previous 30 days
- •Right pleurodesis or fibrothorax
- •Right stroke outcomes
- •Technical impossibility to perform ultrasound evaluations
- •conditions, clinical or otherwise, that in the investigator's judgment may interfere with the study, or not recommending participation for security reasons
- •Absence of written informed consent
结局指标
主要结局
Variations of diaphragmatic and vastus lateralis muscle function, assessed by US, after 4 weeks of in-hospital Pulmonary Rehabilitation
时间窗: After 4 weeks of Pulmonary Rehabilitation (T1)
Evaluation of the post rehabilitation outcomes in terms of diaphragmatic and vastus lateralis muscle function
Relationship between post rehabilitation changes in diaphragmatic and vastus lateralis muscle function and indicators of pulmonary rehabilitation treatment effectiveness
时间窗: After 4 weeks of Pulmonary Rehabilitation (T1)
Evaluation of the correlation between post rehabilitation qualitative and quantitative diaphragmatic and vastus lateralis muscle ultrasound parameters and indicators of pulmonary rehabilitation treatment effectiveness (mMRC, Modified Medical Research Council, Dyspnea Scale; distance in meters at six minute walking test; respiratory function data; arterial blood gas values)
Relationship between diaphragmatic and vastus lateralis muscle function and severity of illness indicators and respiratory function data
时间窗: At discharge from hospital, estimated average of 10 days for Group A patients, and 28 days for Group B patients
Evaluation of the correlation between qualitative and quantitative diaphragmatic and vastus lateralis muscle ultrasound parameters and the degree of respiratory function impairment
次要结局
- Prediction of hospitalization rate by means of parameters of diaphragmatic and vastus lateralis muscle function(Six months after discharge (T2))
- Prediction of in-hospital mortality by means of parameters of diaphragmatic and vastus lateralis muscle function(At discharge from hospital, estimated average of 10 days for Group A patients, and 28 days for Group B patients)
- Prediction of length of stay by means of parameters of diaphragmatic and vastus lateralis muscle function(At discharge from hospital, estimated average of 10 days for Group A patients, and 28 days for Group B patients)
- Prediction of COPD exacerbation rate by means of parameters of diaphragmatic and vastus lateralis muscle function(Six months after discharge (T2))
- Prediction of mortality rate by means of parameters of diaphragmatic and vastus lateralis muscle function(Six months after discharge (T2))