LUng and Cardiac Ultrasound for REspiratory Distress in ElDerly (LUCREED)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Distress Syndrome; Dyspnea
• Intervention / Treatment: Diagnostic test: diagnostic strategy based on 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.

• Study Type: Interventional
• Enrollment (Estimated): 504
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manon Hebrard; Phone Number: +33 561322271; Email: hebrard.m@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France
    • Recruiting
    • UHToulouse
    • Principal Investigator: Frédéric BALEN, MD
    • Contact: Manon HEBRARD; Email: hebrard.m@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: diagnostic strategy based on lung and cardiac ultrasonography; cardiopulmonary ultrasound performed by the emergency physician, immediately at patient's bed
No Intervention: standard care; diagnostic and therapeutic strategy based on the usual practices of the department and the clinician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
therapeutic inadequacy	therapeutic inadequacy between initiated emergency treatments and the final diagnosis made by expert opinion	Hour 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correct diagnosis	correct diagnosis at the emergency department discharge (compared with final diagnosis made by expert opinion)	emergency department discharge (up to hour 4)
duration of emergency department stay	duration in emergency department (in hours)	emergency department discharge (up to hour 4)
Post-emergency hospital stay	duration in Post-emergency hospital department: in medicine/surgery/obstetrics or follow-up and rehabilitation care (in days)	Day 30
Number of days alive outside hospital between D0 and D30	Number of days alive outside hospital between D0 and D30	Day 30
Care cost	Care cost - Direct and indirect medical cost looking at French social security spendings for patients	Day 30

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Frédéric BALEN, MD, University Hospital, Toulouse

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): February 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Elderly; Dyspnea; Point-of-Care Ultrasound; Respiratory Distress Syndrom
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Respiratory Distress Syndrome; Dyspnea
• Other Study ID Numbers: RC31/23/0386; 2024-A01678-39 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No