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)

Overview

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.

Primary outcome measures

• Correlation Between LUS-Detected Pulmonary Abnormalities and Delirium Occurrence [Time frame: During the hospital stay (assessed daily), up to 30 days]

Secondary outcome measures (7)

• Correlation Between LUS Characteristics and Duration of Delirium [Time frame: 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)]
• Correlation Between LUS Characteristics and PaO2/FiO2 Ratio [Time frame: 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)]
• Correlation Between LUS Characteristics and Duration of Hospitalization [Time frame: 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)]
• Correlation Between LUS Characteristics and 3-Month Readmission and Mortality Rates [Time frame: 3 months after discharge]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 1 center

• Fondazione IRCCS San Gerardo — Monza

Publications

• 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. PMID 33994990
• 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. PMID 36607634
• Limpawattana P, Phungoen P, Mitsungnern T, Laosuangkoon W, Tansangworn N. Atypical presentations of older adults at the emergency department and associated factors. Arch Gerontol Geriatr. 2016 Jan-Feb;62:97-102. doi: 10.1016/j.archger.2015.08.016. Epub 2015 Aug 21. PMID 26323650
• Vetrugno L, Guadagnin GM, Barbariol F, Langiano N, Zangrillo A, Bove T. Ultrasound Imaging for Diaphragm Dysfunction: A Narrative Literature Review. J Cardiothorac Vasc Anesth. 2019 Sep;33(9):2525-2536. doi: 10.1053/j.jvca.2019.01.003. Epub 2019 Jan 4. PMID 30686657
• 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. PMID 33438132
• 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. PMID 30372119
• 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. PMID 31894411
• 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. PMID 30314929

Identifiers

NCT: NCT06670118 · ID 4369_20.03.2024_M bis

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗