Acute Respiratory FailureECO-AGENCT06670118
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
An observational study of Acute Respiratory Failure and Delirium in Old Age, run by University of Milano Bicocca at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Respiratory Failure, Delirium in Old Age, Pneumonia
- How many people
- 480 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2024to 1 Dec 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Andrea AT Ticinesi, MD, PhD, Medical Doctor contact
Italy1 site
Fondazione IRCCS San Gerardo
Monza, MB, 20900
Giuseppe GB Bellelli, giuseppe.bellelli@unimib.it
About this study
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)
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.
Read the 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.
- 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
- Medical subject headings
- Pneumonia, Pulmonary Disease, Chronic Obstructive, Delirium, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the hospital stay (assessed daily), up to 30 days
Secondary outcomes (7)
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.
Measured: During the hospital stay (up to 30 days)
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.
Measured: During the hospital stay (up to 30 days)
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.
Measured: During the hospital stay (up to 30 days)
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.
Measured: During the hospital stay (up to 30 days)
Correlation Between LUS Characteristics and Duration of Hospitalization
The correlation between LUS findings and the duration of hospitalization, measured in days from admission to discharge.
Measured: During the hospital stay (up to 30 days)
Correlation Between LUS Characteristics and In-Hospital Mortality
The correlation between LUS findings and in-hospital mortality. This outcome will include the number of patients who die during hospitalization.
Measured: During the hospital stay (up to 30 days)
Correlation Between LUS Characteristics and 3-Month Readmission and Mortality Rates
The correlation between LUS findings and readmission or mortality within 3 months after hospital discharge. Follow-up will be conducted through phone calls to the patients or caregivers.
Measured: 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe GB Bellelli, Medical Doctor, Principal investigator, University of Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670118
- Sponsor's protocol ID
- ID 4369_20.03.2024_M bis
- Acronym
- ECO-AGE
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33994990Ormseth 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.
PubMed 36607634Limpawattana 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.
PubMed 26323650Vetrugno 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.
PubMed 30686657Kameda 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.
PubMed 33438132Mojoli 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.
PubMed 30372119Islam 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.
PubMed 31894411Staub 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.
PubMed 30314929Diaz-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.
PubMed 34670045Okoye 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.
PubMed 40721254
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06670118
- Acronym / sponsor ID
- ECO-AGE / ID 4369_20.03.2024_M bis
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (7 listed)
- 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).
- Lung ultrasound (LUS) performed within 48 hours of admission for clinical reasons.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation Between LUS-Detected Pulmonary Abnormalities and Delirium Occurrence
Time frame: During the hospital stay (assessed daily), up to 30 days
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
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Background: PubMed 33994990Bellelli 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.
- Background: PubMed 36607634Ormseth 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.
- Background: PubMed 26323650Limpawattana 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.
- Background: PubMed 30686657Vetrugno 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.
- Background: PubMed 33438132Kameda 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.
- Background: PubMed 30372119Mojoli 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.
- Background: PubMed 31894411Islam 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.
- Background: PubMed 30314929Staub 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.
- Background: PubMed 34670045Diaz-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.
- Derived from this study: PubMed 40721254Okoye 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea AT Ticinesi, MD, PhD, Medical Doctor contact
Giuseppe GB Bellelli, Medical Doctor principal investigator
University of Milano Bicocca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure and Delirium in Old Age, run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chukwuma Okoye CO Okoye, MD, PhD, Medical doctor (+393387139273, chukwuma.okoye@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between LUS-Detected Pulmonary Abnormalities and Delirium Occurrence (time frame: During the hospital stay (assessed daily), up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06670118, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.