Menu
Recruiting NCT06807983

LUng and Cardiac Ultrasound for REspiratory Distress in ElDerly

No phase Interventional Dyspnea Respiratory Distress Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: diagnostic strategy based on lung and cardiac ultrasonography.
Who it may be relevant to
Registry conditions: Dyspnea, Respiratory Distress Syndrome. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of a Management Strategy for Acute Dyspnea in Elderly Subjects Based on the Use of Lung and Cardiac Ultrasonography

Overview

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.

Interventions

  • Diagnostic test diagnostic strategy based on lung and cardiac ultrasonography
    cardiopulmonary ultrasound performed by the emergency physician, immediately at patient's bed

Primary outcome measures

  • therapeutic inadequacy [Time frame: Hour 1]
Secondary outcome measures (5)
  • correct diagnosis [Time frame: emergency department discharge (up to hour 4)]
  • duration of emergency department stay [Time frame: emergency department discharge (up to hour 4)]
  • Post-emergency hospital stay [Time frame: Day 30]
  • Number of days alive outside hospital between D0 and D30 [Time frame: Day 30]
  • Care cost [Time frame: Day 30]

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 <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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

France · 1 center
  • UHToulouse — Toulouse

Publications

  • Balen F, Hebrard M, Delmas C, Dubucs X, Noel-Savina E, Costa N, Shourick J; LUC REED investigators; and the LUC REED investigators. Lung and cardiac ultrasound for respiratory distress in the elderly: study protocol of the LUC REED stepped-wedge cluster randomised trial. BMJ Open. 2025 Aug 16;15(8):e104715. doi: 10.1136/bmjopen-2025-104715. PMID 40819865

Identifiers

NCT: NCT06807983 · RC31/23/0386 · 2024-A01678-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗