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

June 20, 2023 updated by: IRCCS San Raffaele Roma

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
A
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
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?

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
Time Frame: 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
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
Time Frame: After 4 weeks of Pulmonary Rehabilitation (T1)
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
Time Frame: 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)
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: Six months after discharge (T2)
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
Time Frame: Six months after discharge (T2)
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
Time Frame: Six months after discharge (T2)
Evaluation the ability of qualitative and quantitative US parameters to predict mortality rate six months after the discharge
Six months after discharge (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele Roma

Investigators

  • Principal Investigator: Vittoria Conti, PhD, Unit of Pulmonay Rehabilitation, IRCCS San Raffaele Pisana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

August 3, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP 19/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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