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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

ConditionsAcute Respiratory FailureDelirium in Old AgePneumoniaAcute Heart Failure (AHF)Chronic Obstructive Pulmonary Disease (COPD)Ultrasound Exams
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorUniversity of Milano Bicocca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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).

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

480 Participants
are grouped into 2 trial groups
Group A: Patients with Normal Lung Ultrasound (LUS) Findings
Group B: Patients with Abnormal Lung Ultrasound (LUS) Findings

Trial outcomes

Primary outcomes

1

Correlation Between LUS-Detected Pulmonary Abnormalities and Delirium Occurrence

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

Time frame
During the hospital stay (assessed daily), up to 30 days

Secondary outcomes

1

Correlation Between LUS Characteristics and Duration of Delirium

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.

Time frame
During the hospital stay (up to 30 days)
2

Correlation Between LUS Characteristics and Duration of Oxygen Administration

The correlation between LUS findings and the duration of oxygen therapy, measured in days. Oxygen therapy duration will be tracked throughout hospitalization.

Time frame
During the hospital stay (up to 30 days)
3

Correlation Between LUS Characteristics and PaO2/FiO2 Ratio

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.

Time frame
During the hospital stay (up to 30 days)
4

Correlation Between LUS Characteristics and Need for Non-Invasive Ventilation (NIV)

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.

Time frame
During the hospital stay (up to 30 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Milano Bicocca

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: