Clinical trial NCT06670118: 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
Official title: 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)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Respiratory Failure
Delirium in Old Age
Pneumonia
Acute Heart Failure (AHF)
Chronic Obstructive Pulmonary Disease (COPD)
Ultrasound Exams
Keywords: Lung Ultrasound Abnormalities in Older Adults
Lung ultrasound
delirium
respiratory failure
geriatrics
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 480
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation Between LUS-Detected Pulmonary Abnormalities and Delirium Occurrence
timeFrame: During the hospital stay (assessed daily), up to 30 days
Secondary outcomes:
measure: Correlation Between LUS Characteristics and Duration of Delirium
timeFrame: During the hospital stay (up to 30 days)
measure: Correlation Between LUS Characteristics and Duration of Oxygen Administration
timeFrame: During the hospital stay (up to 30 days)
measure: Correlation Between LUS Characteristics and PaO2/FiO2 Ratio
timeFrame: During the hospital stay (up to 30 days)
measure: Correlation Between LUS Characteristics and Need for Non-Invasive Ventilation (NIV)
timeFrame: During the hospital stay (up to 30 days)
measure: Correlation Between LUS Characteristics and Duration of Hospitalization
timeFrame: During the hospital stay (up to 30 days)
measure: Correlation Between LUS Characteristics and In-Hospital Mortality
timeFrame: During the hospital stay (up to 30 days)
measure: Correlation Between LUS Characteristics and 3-Month Readmission and Mortality Rates
timeFrame: 3 months after discharge
Other outcomes:
Locations:
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo
state: MB
Study officials:
affiliation: University of Milano Bicocca
name: Giuseppe GB Bellelli, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bellelli G, Brathwaite JS, Mazzola P. Delirium: A Marker of Vulnerability in Older People. Front Aging Neurosci. 2021 Apr 30;13:626127. doi: 10.3389/fnagi.2021.626127. eCollection 2021.
citation: Ormseth CH, LaHue SC, Oldham MA, Josephson SA, Whitaker E, Douglas VC. Predisposing and Precipitating Factors Associated With Delirium: A Systematic Review. JAMA Netw Open. 2023 Jan 3;6(1):e2249950. doi: 10.1001/jamanetworkopen.2022.49950.
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citation: Kameda T, Mizuma Y, Taniguchi H, Fujita M, Taniguchi N. Point-of-care lung ultrasound for the assessment of pneumonia: a narrative review in the COVID-19 era. J Med Ultrason (2001). 2021 Jan;48(1):31-43. doi: 10.1007/s10396-020-01074-y. Epub 2021 Jan 13.
citation: Mojoli F, Bouhemad B, Mongodi S, Lichtenstein D. Lung Ultrasound for Critically Ill Patients. Am J Respir Crit Care Med. 2019 Mar 15;199(6):701-714. doi: 10.1164/rccm.201802-0236CI.
citation: Islam M, Levitus M, Eisen L, Shiloh AL, Fein D. Lung Ultrasound for the Diagnosis and Management of Acute Respiratory Failure. Lung. 2020 Feb;198(1):1-11. doi: 10.1007/s00408-019-00309-1. Epub 2020 Jan 1.
citation: Staub LJ, Mazzali Biscaro RR, Kaszubowski E, Maurici R. Lung Ultrasound for the Emergency Diagnosis of Pneumonia, Acute Heart Failure, and Exacerbations of Chronic Obstructive Pulmonary Disease/Asthma in Adults: A Systematic Review and Meta-analysis. J Emerg Med. 2019 Jan;56(1):53-69. doi: 10.1016/j.jemermed.2018.09.009. Epub 2018 Oct 9.
citation: Diaz-Gomez JL, Mayo PH, Koenig SJ. Point-of-Care Ultrasonography. N Engl J Med. 2021 Oct 21;385(17):1593-1602. doi: 10.1056/NEJMra1916062. No abstract available.