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

NCT06670118 | Not Yet Recruiting

• 1 other identifier: ID 4369_20.03.2024_M bis
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

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

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

Secondary Outcomes (7)

• Correlation Between LUS Characteristics and Duration of Delirium

  During the hospital stay (up to 30 days)

• Correlation Between LUS Characteristics and Duration of Oxygen Administration

  During the hospital stay (up to 30 days)

• Correlation Between LUS Characteristics and PaO2/FiO2 Ratio

  During the hospital stay (up to 30 days)

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

  During the hospital stay (up to 30 days)

• Correlation Between LUS Characteristics and Duration of Hospitalization

  During the hospital stay (up to 30 days)

Study Arms (2)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

Fondazione IRCCS San Gerardo

Monza, MB, 20900, Italy

Location

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 34670045 BACKGROUND

• Okoye C, Ticinesi A, Finazzi A, Bruni AA, Guarino D, Cerundolo N, Nouvenne A, Siniscalchi C, Meschi T, Lauretani F, Maggio M, Zucchini I, Torrini M, Cerasuolo M, Rizzo MR, Monzani F, Antonelli Incalzi R, Ungar A, Bellelli G, Scarlata S; GRETA research group on thoracic ultrasound in the older patient, Italian Society of Geriatrics and Gerontology (SIGG). Exploring the correlations of lung ultrasound with delirium and other clinical outcomes in older patients with respiratory failure admitted in acute geriatric units (ECO-AGE): protocol for a multicentre, prospective, observational study from the GRETA Group (Gruppo di Ricerca in Ecografia Toracica nell'Anziano) of the Italian Society of Gerontology and Geriatrics (SIGG). BMJ Open. 2025 Jul 28;15(7):e097229. doi: 10.1136/bmjopen-2024-097229.

  PMID: 40721254 DERIVED

MeSH Terms

Conditions

Pneumonia; Pulmonary Disease, Chronic Obstructive; Delirium; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Respiration Disorders

Study Officials

• Giuseppe GB Bellelli, Medical Doctor

  University of Milano Bicocca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chukwuma Okoye CO Okoye, MD, PhD, Medical doctor

CONTACT

+393387139273; chukwuma.okoye@unimib.it

Andrea AT Ticinesi, MD, PhD, Medical Doctor

CONTACT

andrea.ticinesi@unipr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 1, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

IT (1)