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

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

Sponsors

Lead Sponsor: IRCCS San Raffaele

Source IRCCS San Raffaele
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.

Overall Status Not yet recruiting
Start Date October 2020
Completion Date May 2022
Primary Completion Date October 2021
Study Type Observational
Primary Outcome
Measure Time Frame
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
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)
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)
Secondary Outcome
Measure Time Frame
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
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
Prediction of COPD exacerbation rate by means of parameters of diaphragmatic and vastus lateralis muscle function Six months after discharge (T2)
Prediction of hospitalization rate by means of parameters of diaphragmatic and vastus lateralis muscle function Six months after discharge (T2)
Prediction of mortality rate by means of parameters of diaphragmatic and vastus lateralis muscle function Six months after discharge (T2)
Enrollment 200
Condition
Eligibility

Sampling Method: Probability Sample

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

Gender: All

Minimum Age: 60 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Vittoria Conti, PhD Principal Investigator Unit of Pulmonay Rehabilitation, IRCCS San Raffaele Pisana
Overall Contact

Last Name: Vittoria Conti, PhD

Phone: 0039 338 2163293

Email: [email protected]

Verification Date

August 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: IRCCS San Raffaele

Investigator Full Name: Vittoria Conti

Investigator Title: First Level Medical Manager, Department of Respiratory Disease

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: 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.

Label: 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.

Acronym EDIFEB
Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov