Lung and heart ultrasound for acute breathlessness in older adults
Impact of a Management Strategy for Acute Dyspnea in Elderly Subjects Based on the Use of Lung and Cardiac Ultrasonography
This project will test whether using bedside lung and heart ultrasound helps doctors quickly find the cause and give the right treatment for sudden breathlessness in people over 65.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 504 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT06807983 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized trial at the University Hospital Toulouse enrolling patients aged 65 and older who present to the ED with acute dyspnea and signs of severity. Participants are randomized to standard care or to a clinical ultrasound strategy in which emergency physicians trained in lung and cardiac point-of-care ultrasound perform bedside scans to guide initial management. Treatments started in the ED are recorded and compared with final diagnoses to measure initial therapeutic inadequacy. Patients with recent chest trauma, clear COVID-19, known pulmonary fibrosis or lung cancer, prior specific treatment for the episode, immediate need for intubation, end-of-life status, or legal incapacity are excluded.
Who should consider this trial
Good fit: Ideal candidates are people 65 or older who present to the ED with acute dyspnea within 14 days, have respiratory rate ≥22 and SpO2 <92% on room air, can consent (or have a legal representative), and are managed by an emergency physician trained in lung and cardiac ultrasound.
Not a fit: Patients whose dyspnea is due to chest trauma, clearly related to COVID-19, who have known pulmonary fibrosis or lung cancer, who already received specific treatment before inclusion, who need immediate intubation, who are identified as end-of-life, or who are under legal guardianship or deprived of liberty are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce delays and mistakes in initial treatment and may lower complications and short-term mortality among elderly patients with acute dyspnea.
How similar studies have performed: Previous studies of point-of-care lung and cardiac ultrasound have improved diagnostic accuracy and guided treatment decisions in dyspneic patients, but randomized data specifically measuring outcomes in elderly ED populations are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Eligible patients will be aged over 65 years, affiliated with the French social security system, and presenting to the ED with acute dyspnea (onset \<14 days) accompanied by severity signs before or at triage (respiratory rate ≥22 and SpO2 \<92% on room air). The enrolling emergency physician (EP) must be the patient's treating physician and must be trained in LuCUS. Written informed consent from the patient or their legal representative is required for inclusion Exclusion Criteria: dyspnea secondary to thoracic trauma, dyspnea clearly related to COVID-19, known pulmonary fibrosis or lung cancer, prior administration of specific treatment for dyspnea before inclusion, immediate need for endotracheal intubation, patients identified as being at end-of-life, and individuals under legal guardianship or deprived of liberty.
Where this trial is running
Toulouse
- UHToulouse — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Frédéric BALEN, MD — University Hospital, Toulouse
- Study coordinator: Manon Hebrard
- Email: hebrard.m@chu-toulouse.fr
- Phone: 561322271
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.