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

NCT04509128 | Unknown

• 1 other identifier: RP 19/19
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Keywords

Multidimensional evaluation; COPD; Pulmonary rehabilitation; Diaphragmatic ultrasound; Vastus lateralis muscle ultrasound

Outcome Measures

Primary Outcomes (3)

• Relationship between diaphragmatic and vastus lateralis muscle function and severity of illness indicators and respiratory function data

  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

  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

  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 Outcomes (5)

• 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)

Study Arms (2)

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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
• 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
• Pleural effusion extended for more than two intercostal spaces
• Interstitial lung diseases

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

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Related Links

• GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vittoria Conti, PhD

  Unit of Pulmonay Rehabilitation, IRCCS San Raffaele Pisana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vittoria Conti, PhD

CONTACT

0039 338 2163293; vittoria.conti@sanraffaele.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 11, 2020
• Study Start: December 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: April 1, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06