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

NCT ID: NCT04509128

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2024-04-30

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.

Conditions

COPD; COPD Exacerbation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• COPD diagnosis
• previous or actual cigarette smoking history
• COPD exacerbation requiring hospitalization
• Obtained written informed consent

• 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

• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele Roma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vittoria Conti, PhD

Role: PRINCIPAL_INVESTIGATOR

Unit of Pulmonay Rehabilitation, IRCCS San Raffaele Pisana

Central Contacts

Vittoria Conti, PhD

Role: CONTACT

vittoria.conti@sanraffaele.it

0039 338 2163293

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Related Links

https://goldcopd.org/wp-content/uploads/2018/11/GOLD-2019-v1.7-FINAL-14Nov2018-WMS.pdf

GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines

Other Identifiers

RP 19/19

Identifier Type: -

Identifier Source: org_study_id