Exploring the Correlations of Lung Ultrasound with Delirium and Outcomes in Acute GEriatrics Worl… (NCT06670118) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
Italy480 participantsStarted 2024-12-01
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation Between LUS-Detected Pulmonary Abnormalities and Delirium Occurrence
Timeframe: During the hospital stay (assessed daily), up to 30 days