COPD, COPD Exacerbation
Conditions
Keywords
Multidimensional evaluation, COPD, Pulmonary rehabilitation, Diaphragmatic ultrasound, Vastus lateralis muscle ultrasound
Brief summary
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.
Interventions
None listed
Sponsors
IRCCS San Raffaele Roma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relationship between diaphragmatic and vastus lateralis muscle function and severity of illness indicators and respiratory function data | 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 |
| Variations of diaphragmatic and vastus lateralis muscle function, assessed by US, after 4 weeks of in-hospital Pulmonary Rehabilitation | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prediction of hospitalization rate by means of parameters of diaphragmatic and vastus lateralis muscle function | Six months after discharge (T2) | Evaluation the ability of qualitative and quantitative US parameters to predict hospitalization rate six months after the discharge |
| 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 | Evaluation of the ability of qualitative and quantitative diaphragmatic and vastus lateralis muscle ultrasound parameters to predict in-hospital mortality |
| Prediction of mortality rate by means of parameters of diaphragmatic and vastus lateralis muscle function | Six months after discharge (T2) | Evaluation the ability of qualitative and quantitative US parameters to predict mortality rate six months after the discharge |
| 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 | Evaluation of the ability of qualitative and quantitative diaphragmatic and vastus lateralis muscle ultrasound parameters to predict length of stay |
| Prediction of COPD exacerbation rate by means of parameters of diaphragmatic and vastus lateralis muscle function | Six months after discharge (T2) | Evaluation the ability of qualitative and quantitative US parameters to predict COPD exacerbation rate six months after the discharge |
Contacts
Primary ContactVittoria Conti, PhD
Outcome results
None listed