Exploring the Correlations of Lung Ultrasound with Delirium and Outcomes in Acute GEriatrics World: a Multicenter, Prospective, Observational Study from the GRETA Group of the Italian Society of Gerontology and Geriatrics (ECO-AGE)

October 31, 2024 updated by: University of Milano Bicocca

EXPLORING the CORRELATION of the LUNG ULTRASOUND with DELIRIUM and OUTCOMES in ACUTE GERIATRICS WORLD (ECO-AGE): a MULTICENTER, PROSPECTIVE, OBSERVATIONAL STUDY from the GRETA GROUP (GRUPPO DI RICERCA in ECOGRAFIA TORACICA NELL' ANZIANO) of the ITALIAN SOCIETY of GERONTOLOGY and GERIATRICS (SIGG)

The purpose of this observational study is to investigate the prognostic relevance of lung ultrasound (LUS) performed on older patients (aged 65 and above) admitted to the hospital with acute respiratory symptoms. The primary objective is to determine if LUS-detected pulmonary abnormalities upon hospital admission are associated with the development of delirium during hospitalization. Secondary objectives include assessing the association between LUS patterns and clinical outcomes such as oxygen supplementation duration, non-invasive ventilation use, mortality, and length of hospital stay. This study involves no interventions and will monitor patients using LUS as part of their regular clinical care in multiple centers.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

This is a multicenter, prospective, observational study designed to explore the prognostic value of lung ultrasound (LUS) in older patients admitted with acute respiratory symptoms. The study, titled "Exploring the Correlations of Lung Ultrasound with Delirium and Outcomes in Acute Geriatrics world (ECO-AGE)," aims to evaluate whether the presence of LUS abnormalities, such as pleural or lung parenchymal changes, detected upon admission is associated with the onset of delirium during hospitalization.

The study will recruit participants aged 65 years or older who are admitted to the hospital through the emergency room due to acute respiratory complaints (e.g., dyspnea, cough, reduced oxygen saturation, clinical suspicion of pneumonia, acute heart failure, or chronic obstructive pulmonary disease). Patients will undergo LUS as part of their routine clinical management, and data collected from the LUS exams will be analyzed to assess correlations with clinical outcomes.

The primary endpoint of the study is the incidence of delirium, measured using the 4AT scale, during the hospital stay. Secondary endpoints include associations between LUS patterns and the following outcomes:

Duration of oxygen therapy Requirement for non-invasive mechanical ventilation Length of hospital stay In-hospital mortality Readmission rates and mortality at 3 months post-discharge The study hypothesizes that certain LUS abnormalities, such as diffuse or focal comet-tail artifacts (B-lines), pleural effusion, or parenchymal consolidations, will be predictive of adverse outcomes like delirium or prolonged respiratory support.

Data will be collected via electronic Case Report Forms (eCRFs) and analyzed using multivariate regression models, adjusting for potential confounders such as age, sex, frailty, and comorbidities. The estimated recruitment period is 12 months, and patient outcomes will be monitored throughout hospitalization and for 3 months following discharge. The findings of this study are expected to inform better risk stratification and clinical management of older patients with acute respiratory illnesses.

Study Type

Observational

Enrollment (Estimated)

480

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

Study Contact Backup

Study Locations

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

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of patients aged 65 years and older admitted to participating hospitals through the emergency room or emergency medical services with acute respiratory symptoms (e.g., dyspnea, cough, low oxygen saturation). These patients will undergo lung ultrasound (LUS) as part of their routine clinical management. The study will focus on older adults presenting with conditions such as pneumonia, acute congestive heart failure, chronic obstructive pulmonary disease (COPD), pleural effusion, or pneumothorax. The population will include both male and female patients from multiple centers across Italy, with a particular focus on those at higher risk of delirium and poor clinical outcomes due to underlying frailty or multimorbidity.

Description

Inclusion Criteria:

  • Patients aged 65 years or older, admitted directly from the Emergency Room or Emergency Medical Services with acute respiratory symptoms or signs.

Presence of acute respiratory symptoms, including:

  • Dyspnea or cough.
  • Oxygen saturation less than 94% or respiratory rate ≥ 22 breaths per minute, or PaO2/FiO2 < 300.
  • Clinical suspicion of acute respiratory illness (e.g., pneumonia, acute congestive heart failure, pulmonary edema, COPD, pleural effusion, pneumothorax).
  • Lung ultrasound (LUS) performed within 48 hours of admission for clinical reasons.
  • Signed informed consent for participation in the study.

Exclusion Criteria:

  • Presence of delirium upon admission.
  • Refusal to sign the informed consent form or consent to data collection.
  • Terminal illness with an estimated survival prognosis of no more than 3 months.
  • Previous open thoracic or cardiothoracic surgery compromising the quality of LUS images.
  • Lack of cooperation during the LUS examination.
  • Any condition determined by the investigators that could introduce bias into the study or compromise the quality of the LUS examination.

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
Patients with Normal Lung Ultrasound (LUS) Findings
This cohort includes patients aged 65 and older admitted with acute respiratory symptoms who undergo lung ultrasound (LUS) upon hospital admission. LUS findings in this cohort show normal lung conditions with no significant pleural or parenchymal abnormalities (e.g., no comet-tail artifacts, consolidations, or effusions). The primary interest is to assess the absence of LUS abnormalities and their correlation with clinical outcomes, including delirium, oxygen therapy, and mortality.
Patients with Abnormal Lung Ultrasound (LUS) Findings
This cohort includes patients aged 65 and older admitted with acute respiratory symptoms who undergo lung ultrasound (LUS) upon hospital admission. LUS findings in this cohort show significant abnormalities such as pleural effusions, consolidations, or diffuse comet-tail artifacts (B-lines). The primary interest is to assess the presence of LUS abnormalities and their correlation with clinical outcomes, including delirium, duration of hospitalization, need for oxygen therapy, non-invasive ventilation, and mortality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation Between LUS-Detected Pulmonary Abnormalities and Delirium Occurrence
Time Frame: During the hospital stay (assessed daily), up to 30 days
The primary outcome measure is the correlation between lung ultrasound (LUS)-detected pulmonary abnormalities and the occurrence of delirium, assessed daily using the 4AT scale during hospitalization
During the hospital stay (assessed daily), up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation Between LUS Characteristics and Duration of Delirium
Time Frame: During the hospital stay (up to 30 days)
The duration of delirium, measured in days, will be correlated with LUS characteristics. Delirium duration will be evaluated using daily assessments with the 4AT scale.
During the hospital stay (up to 30 days)
Correlation Between LUS Characteristics and Duration of Oxygen Administration
Time Frame: During the hospital stay (up to 30 days)
The correlation between LUS findings and the duration of oxygen therapy, measured in days. Oxygen therapy duration will be tracked throughout hospitalization.
During the hospital stay (up to 30 days)
Correlation Between LUS Characteristics and PaO2/FiO2 Ratio
Time Frame: During the hospital stay (up to 30 days)
The correlation between LUS findings and the ratio of arterial oxygen pressure (PaO2) to fractional inspired oxygen (FiO2), based on blood gas analyses during hospitalization.
During the hospital stay (up to 30 days)
Correlation Between LUS Characteristics and Need for Non-Invasive Ventilation (NIV)
Time Frame: During the hospital stay (up to 30 days)
The correlation between LUS findings and the requirement for non-invasive ventilation (NIV). The need for NIV and the duration of ventilatory support will be recorded.
During the hospital stay (up to 30 days)
Correlation Between LUS Characteristics and Duration of Hospitalization
Time Frame: During the hospital stay (up to 30 days)
The correlation between LUS findings and the duration of hospitalization, measured in days from admission to discharge.
During the hospital stay (up to 30 days)
Correlation Between LUS Characteristics and In-Hospital Mortality
Time Frame: During the hospital stay (up to 30 days)
The correlation between LUS findings and in-hospital mortality. This outcome will include the number of patients who die during hospitalization.
During the hospital stay (up to 30 days)
Correlation Between LUS Characteristics and 3-Month Readmission and Mortality Rates
Time Frame: 3 months after discharge
The correlation between LUS findings and readmission or mortality within 3 months after hospital discharge. Follow-up will be conducted through phone calls to the patients or caregivers.
3 months after discharge

Collaborators and Investigators

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

Sponsor

University of Milano Bicocca

Investigators

  • Principal Investigator: Giuseppe GB Bellelli, Medical Doctor, University of Milano Bicocca

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

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, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 31, 2024

First Submitted That Met QC Criteria

October 31, 2024

First Posted (Estimated)

November 1, 2024

Study Record Updates

Last Update Posted (Estimated)

November 1, 2024

Last Update Submitted That Met QC Criteria

October 31, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID 4369_20.03.2024_M bis

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

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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