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RecruitingNCT06807983LUCREEDUpdated Dec 4, 2025

LUng and Cardiac Ultrasound for REspiratory Distress in ElDerly

An interventional study of diagnostic strategy based on lung and cardiac ultrasonography in Dyspnea and Respiratory Distress Syndrome, sponsored by University Hospital, Toulouse. Recruiting at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-12-04.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Nov 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
504
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dyspnea
  • Respiratory Distress Syndrome

Keywords

  • Elderly
  • Point-of-Care Ultrasound
  • Respiratory Distress Syndrom
  • Dyspnea
03

In context

Dyspnea

655 studies on the registry are indexed under Dyspnea; 153 are open to participants now.

This study's planned enrollment of 504 is above the median of 48 across 429 interventional studies indexed under Dyspnea.

Browse Dyspnea studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
504 participants (estimated)

Study arms

  • 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

  • No intervention
    standard care

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

Interventions

  • Diagnostic testdiagnostic strategy based on lung and cardiac ultrasonography

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

06

What researchers measure

Primary outcomes

  1. therapeutic inadequacy

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

    Time frame: Hour 1

Secondary outcomes

  1. correct diagnosis

    correct diagnosis at the emergency department discharge (compared with final diagnosis made by expert opinion)

    Time frame: emergency department discharge (up to hour 4)

  2. duration of emergency department stay

    duration in emergency department (in hours)

    Time frame: emergency department discharge (up to hour 4)

  3. Post-emergency hospital stay

    duration in Post-emergency hospital department: in medicine/surgery/obstetrics or follow-up and rehabilitation care (in days)

    Time frame: Day 30

  4. Number of days alive outside hospital between D0 and D30

    Number of days alive outside hospital between D0 and D30

    Time frame: Day 30

  5. Care cost

    Care cost - Direct and indirect medical cost looking at French social security spendings for patients

    Time frame: Day 30

07

Study locations

1 of 1 sites recruiting
  • UHToulouse
    Toulouse, France
    Recruiting
08

References and documents

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. PubMed 40819865 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06807983
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Feb 4, 2025
Start date
Nov 4, 2025
Primary completion
May 1, 2027 (estimated)
Completion
May 1, 2027 (estimated)
Last update
Dec 4, 2025

Study contacts

Manon Hebrard
Contact
hebrard.m@chu-toulouse.fr
561322271 ext. +33
Frédéric BALEN, MD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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