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)

University of Milano Bicocca

Status: Not yet enrolling

Conditions: Acute Heart Failure (AHF); Ultrasound Exams; Pneumonia; Delirium in Old Age; Acute Respiratory Failure; Chronic Obstructive Pulmonary Disease (COPD)

Study type: Observational

Funder types: Other

Identifiers

NCT06670118

ID 4369_20.03.2024_M bis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

480 participants in 2 patient groups

Patients with Normal Lung Ultrasound (LUS) Findings

Description:

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

Description:

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.