Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT06670118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-01
First Post:
2024-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2024-10-31', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation Between LUS-Detected Pulmonary Abnormalities and Delirium Occurrence', 'timeFrame': 'During the hospital stay (assessed daily), up to 30 days', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Correlation Between LUS Characteristics and Duration of Delirium', 'timeFrame': 'During the hospital stay (up to 30 days)', 'description': '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.'}, {'measure': 'Correlation Between LUS Characteristics and Duration of Oxygen Administration', 'timeFrame': 'During the hospital stay (up to 30 days)', 'description': 'The correlation between LUS findings and the duration of oxygen therapy, measured in days. Oxygen therapy duration will be tracked throughout hospitalization.'}, {'measure': 'Correlation Between LUS Characteristics and PaO2/FiO2 Ratio', 'timeFrame': 'During the hospital stay (up to 30 days)', 'description': '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.'}, {'measure': 'Correlation Between LUS Characteristics and Need for Non-Invasive Ventilation (NIV)', 'timeFrame': 'During the hospital stay (up to 30 days)', 'description': '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.'}, {'measure': 'Correlation Between LUS Characteristics and Duration of Hospitalization', 'timeFrame': 'During the hospital stay (up to 30 days)', 'description': 'The correlation between LUS findings and the duration of hospitalization, measured in days from admission to discharge.'}, {'measure': 'Correlation Between LUS Characteristics and In-Hospital Mortality', 'timeFrame': 'During the hospital stay (up to 30 days)', 'description': 'The correlation between LUS findings and in-hospital mortality. This outcome will include the number of patients who die during hospitalization.'}, {'measure': 'Correlation Between LUS Characteristics and 3-Month Readmission and Mortality Rates', 'timeFrame': '3 months after discharge', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung Ultrasound Abnormalities in Older Adults', 'Lung ultrasound', 'delirium', 'respiratory failure', 'geriatrics'], 'conditions': ['Acute Respiratory Failure', 'Delirium in Old Age', 'Pneumonia', 'Acute Heart Failure (AHF)', 'Chronic Obstructive Pulmonary Disease (COPD)', 'Ultrasound Exams']}, 'referencesModule': {'references': [{'pmid': '33994990', 'type': 'BACKGROUND', '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.'}, {'pmid': '36607634', 'type': 'BACKGROUND', '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.'}, {'pmid': '26323650', 'type': 'BACKGROUND', 'citation': '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': '30686657', 'type': 'BACKGROUND', 'citation': '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': '33438132', 'type': 'BACKGROUND', '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.'}, {'pmid': '30372119', 'type': 'BACKGROUND', '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.'}, {'pmid': '31894411', 'type': 'BACKGROUND', '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.'}, {'pmid': '30314929', 'type': 'BACKGROUND', '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.'}, {'pmid': '34670045', 'type': 'BACKGROUND', '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.'}, {'pmid': '40721254', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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:\n\nDuration 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.\n\nData 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 65 years or older, admitted directly from the Emergency Room or Emergency Medical Services with acute respiratory symptoms or signs.\n\nPresence of acute respiratory symptoms, including:\n\n* Dyspnea or cough.\n* Oxygen saturation less than 94% or respiratory rate ≥ 22 breaths per minute, or PaO2/FiO2 \\< 300.\n* Clinical suspicion of acute respiratory illness (e.g., pneumonia, acute congestive heart failure, pulmonary edema, COPD, pleural effusion, pneumothorax).\n* Lung ultrasound (LUS) performed within 48 hours of admission for clinical reasons.\n* Signed informed consent for participation in the study.\n\nExclusion Criteria:\n\n* Presence of delirium upon admission.\n* Refusal to sign the informed consent form or consent to data collection.\n* Terminal illness with an estimated survival prognosis of no more than 3 months.\n* Previous open thoracic or cardiothoracic surgery compromising the quality of LUS images.\n* Lack of cooperation during the LUS examination.\n* Any condition determined by the investigators that could introduce bias into the study or compromise the quality of the LUS examination.'}, 'identificationModule': {'nctId': 'NCT06670118', 'acronym': 'ECO-AGE', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'University of Milano Bicocca'}, 'officialTitle': "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)", 'orgStudyIdInfo': {'id': 'ID 4369_20.03.2024_M bis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Normal Lung Ultrasound (LUS) Findings', 'description': '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.'}, {'label': 'Patients with Abnormal Lung Ultrasound (LUS) Findings', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20900', 'city': 'Monza', 'state': 'MB', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe GB Bellelli', 'role': 'CONTACT', 'email': 'giuseppe.bellelli@unimib.it', 'phoneExt': '00393392777327'}], 'facility': 'Fondazione IRCCS San Gerardo', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}], 'centralContacts': [{'name': 'Chukwuma Okoye CO Okoye, MD, PhD, Medical doctor', 'role': 'CONTACT', 'email': 'chukwuma.okoye@unimib.it', 'phone': '+393387139273'}, {'name': 'Andrea AT Ticinesi, MD, PhD, Medical Doctor', 'role': 'CONTACT', 'email': 'andrea.ticinesi@unipr.it'}], 'overallOfficials': [{'name': 'Giuseppe GB Bellelli, Medical Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Milano Bicocca'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milano Bicocca', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}