Clinical trial NCT04509128: Ultrasonographic Evaluation of Diaphragm and Quadriceps in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
COPD Exacerbation
Keywords: Multidimensional evaluation
COPD
Pulmonary rehabilitation
Diaphragmatic ultrasound
Vastus lateralis muscle ultrasound
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Group A: Subjects hospitalizated for a COPD acute exacerbation Group B: Subjects referred for pulmonary rehabilitation (PR) after a hospitalized COPD exacerbation.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Relationship between diaphragmatic and vastus lateralis muscle function and severity of illness indicators and respiratory function data
timeFrame: At discharge from hospital, estimated average of 10 days for Group A patients, and 28 days for Group B patients
measure: Variations of diaphragmatic and vastus lateralis muscle function, assessed by US, after 4 weeks of in-hospital Pulmonary Rehabilitation
timeFrame: After 4 weeks of Pulmonary Rehabilitation (T1)
measure: Relationship between post rehabilitation changes in diaphragmatic and vastus lateralis muscle function and indicators of pulmonary rehabilitation treatment effectiveness
timeFrame: After 4 weeks of Pulmonary Rehabilitation (T1)
Secondary outcomes:
measure: Prediction of in-hospital mortality by means of parameters of diaphragmatic and vastus lateralis muscle function
timeFrame: At discharge from hospital, estimated average of 10 days for Group A patients, and 28 days for Group B patients
measure: Prediction of length of stay by means of parameters of diaphragmatic and vastus lateralis muscle function
timeFrame: At discharge from hospital, estimated average of 10 days for Group A patients, and 28 days for Group B patients
measure: Prediction of COPD exacerbation rate by means of parameters of diaphragmatic and vastus lateralis muscle function
timeFrame: Six months after discharge (T2)
measure: Prediction of hospitalization rate by means of parameters of diaphragmatic and vastus lateralis muscle function
timeFrame: Six months after discharge (T2)
measure: Prediction of mortality rate by means of parameters of diaphragmatic and vastus lateralis muscle function
timeFrame: Six months after discharge (T2)
Other outcomes:
Locations:
Study officials:
affiliation: Unit of Pulmonay Rehabilitation, IRCCS San Raffaele Pisana
name: Vittoria Conti, PhD
role: PRINCIPAL_INVESTIGATOR
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