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

Not yet recruiting

• Conditions: COPD Exacerbation; COPD

• Registration Number: NCT04509128
• Lead Sponsor: IRCCS San Raffaele Roma

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-11
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22
• Study Start: 2023-12
• Primary Completion: 2023-12
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
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

Secondary Outcome Measures

Name	Time	Method
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 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
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