DyspneaLUCREEDNCT06807983
LUng and Cardiac Ultrasound for REspiratory Distress in ElDerly
A study testing diagnostic strategy based on lung and cardiac ultrasonography in people with Dyspnea and Respiratory Distress Syndrome, run by University Hospital, Toulouse at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dyspnea, Respiratory Distress Syndrome
- What is being tested?
- diagnostic strategy based on lung and cardiac ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2025to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
UHToulouse
Toulouse
Manon HEBRARD, hebrard.m@chu-toulouse.fr
Frédéric BALEN, MD
About this study
Official title: 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.
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.
- Conditions
- Dyspnea, Respiratory Distress Syndrome
- Being tested
- diagnostic strategy based on lung and cardiac ultrasonography
- Keywords
- Elderly, Point-of-Care Ultrasound, Respiratory Distress Syndrom, Dyspnea
- Medical subject headings
- Dyspnea, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic strategy based on lung and cardiac ultrasonographyDiagnostic test
cardiopulmonary ultrasound performed by the emergency physician, immediately at patient's bed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
therapeutic inadequacy
therapeutic inadequacy between initiated emergency treatments and the final diagnosis made by expert opinion
Measured: Hour 1
Secondary outcomes (5)
correct diagnosis
correct diagnosis at the emergency department discharge (compared with final diagnosis made by expert opinion)
Measured: emergency department discharge (up to hour 4)
duration of emergency department stay
duration in emergency department (in hours)
Measured: 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)
Measured: Day 30
Number of days alive outside hospital between D0 and D30
Number of days alive outside hospital between D0 and D30
Measured: Day 30
Care cost
Care cost - Direct and indirect medical cost looking at French social security spendings for patients
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start4 Nov 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- stepped-wedge randomized
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric BALEN, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807983
- Sponsor's protocol ID
- RC31/23/0386
- Other IDs
- 2024-A01678-39
- Acronym
- LUCREED
- Status last verified
- Nov 2025
- First submitted
- 22 Jan 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Management Strategy for Acute Dyspnea in Elderly Subjects Based on the Use of Lung and Cardiac Ultrasonography
- ClinicalTrials.gov ID
- NCT06807983
- Acronym / sponsor ID
- LUCREED / RC31/23/0386
- Conditions
- Dyspnea, Respiratory Distress Syndrome
- Keywords
- Elderly, Point-of-Care Ultrasound, Respiratory Distress Syndrom, Dyspnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- stepped-wedge randomized
| Arm | Type | Receives |
|---|---|---|
| clinical ultrasound | Experimental | Diagnostic Test: diagnostic strategy based on lung and cardiac ultrasonographydiagnostic strategy based on the protocolized implementation of clinical lung and cardiac ultrasonography, with a proposed diagnostic and therapeutic focus based on the results. |
| standard care | No intervention | –diagnostic and therapeutic strategy based on the usual practices of the department and the clinician |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnostic strategy based on lung and cardiac ultrasonographycardiopulmonary ultrasound performed by the emergency physician, immediately at patient's bed | Diagnostic test | clinical ultrasound |
Primary outcome
therapeutic inadequacy
Time frame: Hour 1
therapeutic inadequacy between initiated emergency treatments and the final diagnosis made by expert opinion
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Derived from this study: PubMed 40819865Balen 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.
- Individual participant dataSharing planned: No
Related trials for Dyspnea
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Recruiting
The Impact of Telemedicine, Using the Caller's Mobile Phone Camera, on the Quality of Care Provided to Adult Patients Contacting the 15 Centre for Acute Dyspnea
Dyspnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frédéric BALEN, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diagnostic strategy based on lung and cardiac ultrasonography in people with Dyspnea and Respiratory Distress Syndrome, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manon Hebrard (561322271 ext. +33, hebrard.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
therapeutic inadequacy (time frame: Hour 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06807983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.