Ultrasonographic Evaluation of Diaphragm and Quadriceps in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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COPD, COPD Exacerbation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Group A): COPD diagnosis previous or actual cigarette smoking history COPD exacerbation requiring hospitalization 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 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Subjects hospitalized for a COPD acute exacerbation, undergoing arterial blood gas analysis, evaluation of presence and grade of dyspnea, handgrip strength test, and diaphragmatic and vastus lateralis muscle ultrasound assessment, at admission and discharge. | |
| B<br>Subjects referred for pulmonary rehabilitation (PR) after a hospitalized COPD exacerbation, undergoing pulmonary function test, arterial blood gas analysis, evaluation of presence and grade of dyspnea, handgrip strength test, and diaphragmatic and vastus lateralis muscle ultrasound assessment, before and after PR. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between diaphragmatic and vastus lateralis muscle function and severity of illness indicators and respiratory function data | Evaluation of the correlation between qualitative and quantitative diaphragmatic and vastus lateralis muscle ultrasound parameters and the degree of respiratory function impairment | At discharge from hospital, estimated average of 10 days for Group A patients, and 28 days for Group B patients | 
| Variations of diaphragmatic and vastus lateralis muscle function, assessed by US, after 4 weeks of in-hospital Pulmonary Rehabilitation | Evaluation of the post rehabilitation outcomes in terms of diaphragmatic and vastus lateralis muscle function | After 4 weeks of Pulmonary Rehabilitation (T1) | 
| Relationship between post rehabilitation changes in diaphragmatic and vastus lateralis muscle function and indicators of pulmonary rehabilitation treatment effectiveness | 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) | After 4 weeks of Pulmonary Rehabilitation (T1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of in-hospital mortality by means of parameters of diaphragmatic and vastus lateralis muscle function | Evaluation of the ability of qualitative and quantitative diaphragmatic and vastus lateralis muscle ultrasound parameters to predict in-hospital mortality | 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 | Evaluation of the ability of qualitative and quantitative diaphragmatic and vastus lateralis muscle ultrasound parameters to predict length of stay | 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 | Evaluation the ability of qualitative and quantitative US parameters to predict COPD exacerbation rate six months after the discharge | Six months after discharge (T2) | 
| Prediction of hospitalization rate by means of parameters of diaphragmatic and vastus lateralis muscle function | Evaluation the ability of qualitative and quantitative US parameters to predict hospitalization rate six months after the discharge | Six months after discharge (T2) | 
| Prediction of mortality rate by means of parameters of diaphragmatic and vastus lateralis muscle function | Evaluation the ability of qualitative and quantitative US parameters to predict mortality rate six months after the discharge | Six months after discharge (T2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multidimensional evaluation, COPD, Pulmonary rehabilitation, Diaphragmatic ultrasound, Vastus lateralis muscle ultrasound