Clinical trial NCT06807983: LUng and Cardiac Ultrasound for REspiratory Distress in ElDerly
Official title: Impact of a Management Strategy for Acute Dyspnea in Elderly Subjects Based on the Use of Lung and Cardiac Ultrasonography
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dyspnea
Respiratory Distress Syndrome
Keywords: Elderly
Point-of-Care Ultrasound
Respiratory Distress Syndrom
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 504
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: stepped-wedge randomized
Primary purpose: DIAGNOSTIC

Brief summary: Prospective trial to evaluate the impact on the initial therapeutic inadequacy of a management strategy for acute dyspnea in the elderly based on the use of lung and cardiac ultrasonography.

Detailed description: Acute dyspnea is a frequent and serious reason of admission in Emergency Department (ED), with a one-month mortality close to 16%. It is difficult to diagnose in the initial assessment phase since the cause of this symptom can vary (cardiological, pulmonary, infectious, etc.) and the symptoms can be misleading. This difficulty in diagnosing delays the implementation of appropriate therapeutic management even as the timeliness of management is associated with a reduction in mortality. These issues are particularly important in the elderly.

Lung and cardiac ultrasonography performed by the emergency physician, immediately available at the patient's bedside, could reduce the diagnostic and therefore therapeutic delay.

However, the impact of a diagnostic strategy based on lung and cardiac ultrasonography in dyspneic elderly subjects has not been evaluated.

Patients will be randomized in two groups : "standard of care" or "clinical ultrasound" group. Treatments initiated in Emergency Department (ED) will be noted to be compared to final diagnosis.

Eligibility 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 \<7 days) accompanied by severity signs before or at triage (respiratory rate ≥22 or 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.

Primary outcomes:
measure: therapeutic inadequacy
timeFrame: Hour 1
Secondary outcomes:
measure: correct diagnosis
timeFrame: emergency department discharge (up to hour 4)
measure: duration of emergency department stay
timeFrame: emergency department discharge (up to hour 4)
measure: Post-emergency hospital stay
timeFrame: Day 30
measure: Number of days alive outside hospital between D0 and D30
timeFrame: Day 30
measure: Care cost
timeFrame: Day 30
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Toulouse
name: Frédéric BALEN, MD
role: PRINCIPAL_INVESTIGATOR
References: