LUng and Cardiac Ultrasound for REspiratory Distress in ElDerly

NCT06807983 | Recruiting

• 2 other identifiers: RC31/23/03862024-A01678-39
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspnea; Respiratory Distress Syndrome

Keywords

Elderly; Point-of-Care Ultrasound; Respiratory Distress Syndrom; Dyspnea

Outcome Measures

Primary Outcomes (1)

• therapeutic inadequacy

  therapeutic inadequacy between initiated emergency treatments and the final diagnosis made by expert opinion

  Hour 1

Secondary Outcomes (5)

• correct diagnosis

  emergency department discharge (up to hour 4)

• duration of emergency department stay

  emergency department discharge (up to hour 4)

• Post-emergency hospital stay

  Day 30

• Number of days alive outside hospital between D0 and D30

  Day 30

• Care cost

  Day 30

Study Arms (2)

clinical ultrasound

EXPERIMENTAL

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

standard care

NO INTERVENTION

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

Interventions

diagnostic strategy based on lung and cardiac ultrasonography DIAGNOSTIC_TEST

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

clinical ultrasound

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

UHToulouse

Toulouse, France

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Dyspnea; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases

Study Officials

• Frédéric BALEN, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manon Hebrard

CONTACT

561322271; hebrard.m@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: stepped-wedge randomized

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 4, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)