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NCT Number: NCT06807983

LUng and Cardiac Ultrasound for REspiratory Distress in ElDerly

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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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UHToulouse

Toulouse, France

Location status: Recruiting

Location contact

Frédéric BALEN, MD

PRINCIPAL_INVESTIGATOR

Manon HEBRARD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

diagnostic strategy based on lung and cardiac ultrasonography

Diagnostic Test

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

Primary outcomes

  1. therapeutic inadequacy

    Time frame: Hour 1

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

Secondary outcomes

  1. correct diagnosis

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

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

  2. duration of emergency department stay

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

    duration in emergency department (in hours)

  3. Post-emergency hospital stay

    Time frame: Day 30

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

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

    Time frame: Day 30

    Number of days alive outside hospital between D0 and D30

  5. Care cost

    Time frame: Day 30

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

Study contacts

Contact information is provided by the study sponsor or research team.

Manon Hebrard

CONTACT

[email protected]

561322271 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: LUCREED

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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