LUng and Cardiac Ultrasound for REspiratory Distress in ElDerly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-04

Study Completion Date

2027-05-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dyspnea Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

stepped-wedge randomized

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Diagnostic classification and therapeutic adequacy or inadequacy will be established by expert appraisal of the files by 2 experts (a cardiologist and a pulmonologist ) blind to the results of the clinical ultrasound and the the other expert.

Study Groups

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clinical ultrasound

diagnostic strategy based on the protocolized implementation of clinical lung and cardiac ultrasonography, with a proposed diagnostic and therapeutic focus based on the results.

Group Type EXPERIMENTAL

diagnostic strategy based on lung and cardiac ultrasonography

Intervention Type DIAGNOSTIC_TEST

cardiopulmonary ultrasound performed by the emergency physician, immediately at patient's bed

standard care

diagnostic and therapeutic strategy based on the usual practices of the department and the clinician

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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diagnostic strategy based on lung and cardiac ultrasonography

cardiopulmonary ultrasound performed by the emergency physician, immediately at patient's bed

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No