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

IRCCS San Raffaele Roma

Status: Not yet enrolling

Conditions: COPD; COPD Exacerbation

Study type: Observational

Funder types: Other

Identifiers

NCT04509128

RP 19/19

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

200 participants in 2 patient groups

A

Description:

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

Description:

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.