DyspneaEMERALD-USNCT03691857
Feasibility and Accuracy of an Ultrasound Algorithm for Acute Dyspnea Diagnosis in the Emergency Department
A study testing Ultrasound algorithm (EMERALD-US) in people with Dyspnea, run by CHOUIHED Tahar at 7 sites in France.
Trial summary
The management of chest pain has revolutionized its prognosis, primarily by improving urgent diagnosis of myocardial infarction. Currently, acute dyspnea is twice as frequent as chest pain and its associated mortality is much higher (16% of acute dyspnea admitted to emergency departments (ED) ). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- Ultrasound algorithm (EMERALD-US)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 7 sitesFrance
- Study dates
- 14 Dec 2020to 14 Apr 2025
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 50 years old
- Patients with non-traumatic acute dyspnea managed in the emergency department
- Patients affiliated with a social security system
Who cannot join
- Patients in cardiac arrest
- Patients in persistent shock
- Patients with impaired consciousness (Glasgow Score<9)
- Patients with a history of thoracic surgery or pulmonary fibrosis
- Dementia
- Patients with Acute Coronary Syndrome with ST elevation
- Known current pregnancy
- Patients under guardianship, trusteeship or legal protection
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nicolas GIRERD, MD PhD contact
7 sites in 1 country
France7 sites, 6 recruiting
- Recruiting
CH de Chalons en Champagne
Châlons-en-Champagne, 51000
Alice PENINE, MD
- Recruiting
Hôpital Simone Veil
Eaubonne, 95602
Maxime GAUTIER, MD, +33 1 34 06 60 00, maxime.gautier@ch-simoneveil.fr
Maxime GAUTIER, MD
- Recruiting
CHRU Nancy
Nancy, 54500
Tahar CHOUIHED, MD
- Recruiting
AP-HP - Hôpital Cochin
Paris
Jérôme BOKOBZA, MD
- Recruiting
AP-HP - Hôpital Lariboisière
Paris
Anthony CHAUVIN, MD
- Withdrawn
CH de Sarreguemines
Sarreguemines, 57200
- Recruiting
CHRU de Strasbourg, Hôpital de Hautepierre
Strasbourg
Pierrick Le Borgne, Dr
About this study
Official title: Evaluation of the Feasibility and Accuracy of an Ultrasound Algorithm for Acute Dyspnea Diagnosis in the Emergency Department
The management of chest pain has revolutionized its prognosis, primarily by improving urgent diagnosis of myocardial infarction. Currently, acute dyspnea is twice as frequent as chest pain and its associated mortality is much higher (16% of acute dyspnea admitted to emergency departments (ED) ).
Inappropriate treatment of acute dyspnea in the ED is frequent (30%) and is associated with a tripling of intra-hospital mortality after adjustment for confounding factors (2.83, IC 1.48 to 5.41, p=0.002). Other elements have also highlighted the importance of a quick and appropriate acute dyspnea diagnosis:
Read more
- The 2015 European Guidelines on acute heart failure emphasize the need for appropriate treatment within 90 minutes after the first medical contact.
- Inadequate treatment of chronic bronchitis decompensation is associated with a doubling of intra-hospital mortality.
- An initiation of antibiotic treatment within 4 hours of admission for pneumonia is recommended.
- 30% of pulmonary embolisms are not diagnosed during the initial emergency department visit, whereas their mortality in the absence of treatment is 25%.
Lung, venous and (simplified) cardiac ultrasound is associated with improved diagnostic performance in ED. However, no ultrasound algorithm dedicated to emergency physicians has been formally validated. The Blue Protocol (Lichtenstein et al., Chest 2008) has been validated in intensive care patients with very different phenotypes than those admitted to the ED. Pivetta et al. (Chest 2015) proposed an algorithm focused solely for the diagnosis of heart failure, thus not providing a diagnosis for all the other causes of dyspnea in ED. Finally, Zanbonetti et al. (Chest 2017) proposed an "unguided" ultrasound use, notably integrating inferior vena cava evaluation. However, measuring the inferior vena cava is difficult at the start of ED management when patients are in acute respiratory distress.
Read the detailed description
The investigators aim to assess the feasibility and accuracy of a new pragmatic and original ultrasound algorithm adapted for acute dyspnea diagnosis in the emergency department.
This primary objective of this prospective multicenter study is to assess the diagnostic accuracy of an ultrasound algorithm (EMERALD-US) dedicated to emergencies using lung, cardiac and vascular ultrasound for the 3 main dyspnea causes (heart failure, pneumonia and obstructive pulmonary disease exacerbation) in patients with acute non-traumatic dyspnea managed in the emergency department. Ultrasound exams will be blindly read by a centralized core laboratory after the standardized acquisition of all exams by a physician not involved in the care of patients in the ED. The main discharge diagnosis from initial hospitalization (heart failure, pneumonia and obstructive pulmonary disease exacerbation) will be adjudicated by a college of 3 senior physicians (emergency physician, cardiologist and internist) blinded to the use of ultrasound in the ED.
The secondary objectives of the study are to:
A/ Assess the feasibility of the ultrasound algorithm (EMERALD-US) in emergency departments.
B/ Assess the association between the diagnosis obtained from the ultrasound algorithm (EMERALD-US) and the results of additional (laboratory and radiological exams.
C/ Assess the diagnostic accuracy of the ultrasound algorithm (EMERALD-US) for less frequent dyspnea causes (pulmonary embolism, pleural effusion).
D/ Assess, the diagnostic accuracy of clinical (including BREST and PREDICA score), laboratory and radiological variables.
E/ Assess, the improvement in diagnosis accuracy with the ultrasound algorithm (EMERALD-US) on top of the diagnostic accuracy of clinical, laboratory and radiological exams.
F/ Assess the association between misdiagnosis (without using ultrasound) and survival at D30.
- Conditions
- Dyspnea
- Being tested
- Ultrasound algorithm (EMERALD-US)
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound algorithm (EMERALD-US)Procedure or surgery
Ultrasound algorithm EMERALD-US is an dedicated to emergencies using lung, cardiac and vascular ultrasound for the 3 main dyspnea causes (heart failure, pneumonia and obstructive pulmonary disease exacerbation) in patients with acute non-traumatic dyspnea managed in the emergency department. The ultrasounds will be performed within first hour after first medical contact in emergency department by another emergency physician not in charge of the patient. The ultrasound results will be not shared with the emergency physician in charge of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Acute non-traumatic dyspnea patients | Other | Patients with acute non-traumatic dyspnea managed in the emergency department to assess the diagnostic accuracy of an ultrasound algorithm (EMERALD-US) dedicated to emergencies using lung, cardiac and vascular ultrasound for the 3 main dyspnea causes (heart failure, pneumonia and obstructive pulmonary disease exacerbation) Receives: Procedure: Ultrasound algorithm (EMERALD-US) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main discharge diagnosis (heart failure, pneumonia and obstructive pulmonary disease exacerbation)
Main discharge diagnosis (heart failure, pneumonia and obstructive pulmonary disease exacerbation) adjudicated by a college of 3 senior physicians (emergency physician, cardiologist and internist) blinded to the use of ultrasound in the emergency department
Measured: an average of 2 weeks (from date of admission in the emergency department until the date of hospitalization discharge)
Secondary outcomes (10)
Duration of the ultrasound examination
Duration of the ultrasound examination is defined by the delay between the first and last contact between the ultrasound probe and the patient
Measured: up to 30 minutes
Proportion of complete realization of the ultrasound algorithm
Proportion of complete realization of the ultrasound algorithm through study completion
Measured: up to 30 minutes
Diagnosis given by the algorithm after core-lab reading of the blinded ultrasound compared to the diagnosis provided by the emergency physician based on the EMERALD algorithm in the emergency department
Diagnosis given by the algorithm after core-lab reading of the blinded ultrasound compared to the diagnosis provided by the emergency physician based on the EMERALD algorithm in the emergency department
Measured: At baseline
Patient management time in the emergency department
Patient management time in the emergency department is defined by the time between the time of entry to the emergency department and the time of discharge specified in the patient's medical report.
Measured: An average of 24 hours (Time between the time of entry to the emergency department and the time of discharge).
Brain Natriuretic Peptide (BNP) or N-terminal pro-brain natriuretic peptide concentration
Assess the association between the diagnosis obtained from the ultrasound algorithm (EMERALD-US) and the results of additional laboratory exams. NT pro BNP will be measured from the biobanking.
Measured: At admission in the emergency department
C Reactive protein and procalcitonin concentration,
Assess the association between the diagnosis obtained from the ultrasound algorithm (EMERALD-US) and the results of additional local laboratory exams
Measured: At admission in the emergency department
D-dimer concentration,
Assess the association between the diagnosis obtained from the ultrasound algorithm (EMERALD-US) and the results of additional local laboratory exams
Measured: At admission in the emergency department
Radiological diagnosis (chest X-ray or chest CT).
Assess the association between the diagnosis obtained from the ultrasound algorithm (EMERALD-US) and the results of additional local radiological exams
Measured: At admission in the emergency department
Main discharge diagnosis including combined diagnosis (e.g. heart failure and pneumonia) from initial hospitalization adjudicated by a college of 3 senior physicians
Main discharge diagnosis including combined diagnosis (e.g. heart failure and pneumonia) from initial hospitalization adjudicated by a college of 3 senior physicians
Measured: An average of 2 weeks (from date of admission in the emergency department until the date of discharge)
All-cause mortality at D30.
Assess the association between misdiagnosis (without using ultrasound) and survival at D30
Measured: At Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start14 Dec 2020
- Primary completion14 Mar 2025 (estimated)
- Study completion14 Apr 2025 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHOUIHED Tahar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, CHOUIHED Tahar, Central Hospital, Nancy, France
- Investigators
- Tahar CHOUIHED, MD, Principal investigator, Central Hospital, CHRU de Nancy, FranceNicolas GIRERD, MD PhD, Study chair, CHRU de Nancy, FrancePatrick ROSSIGNOL, MD PhD, Study chair, CHRU de Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691857
- Sponsor's protocol ID
- 2018-A02136-49
- Acronym
- EMERALD-US
- Status last verified
- Jan 2025
- First submitted
- 20 Sep 2018
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jaeger D, Duchanois C, Duarte K, Lepage X, Merckle L, Bassand A, Buessler A, Chauvin A, Bokobza J, Penine A, Giacomin G, Brossard C, Girerd N, Chouihed T. Performance of an ultrasound diagnostic algorithm for acute dyspneic patients in the emergency department: an EMERALD-US protocol. BMJ Open. 2025 Aug 10;15(8):e101432. doi: 10.1136/bmjopen-2025-101432.
PubMed 40784781
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility and Accuracy of an Ultrasound Algorithm for Acute Dyspnea Diagnosis in the Emergency Department
- ClinicalTrials.gov ID
- NCT03691857
- Acronym / sponsor ID
- EMERALD-US / 2018-A02136-49
- Conditions
- Dyspnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- CHOUIHED TaharUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 14 Mar 2025 (estimated)
- Study completion
- 14 Apr 2025 (estimated)
- First posted
- 2 Oct 2018 (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.
The management of chest pain has revolutionized its prognosis, primarily by improving urgent diagnosis of myocardial infarction. Currently, acute dyspnea is twice as frequent as chest pain and its associated mortality is much higher (16% of acute dyspnea admitted to emergency departments (ED) ).
Inappropriate treatment of acute dyspnea in the ED is frequent (30%) and is associated with a tripling of intra-hospital mortality after adjustment for confounding factors (2.83, IC 1.48 to 5.41, p=0.002). Other elements have also highlighted the importance of a quick and appropriate acute dyspnea diagnosis:
- The 2015 European Guidelines on acute heart failure emphasize the need for appropriate treatment within 90 minutes after the first medical contact.
- Inadequate treatment of chronic bronchitis decompensation is associated with a doubling of intra-hospital mortality.
- An initiation of antibiotic treatment within 4 hours of admission for pneumonia is recommended.
- 30% of pulmonary embolisms are not diagnosed during the initial emergency department visit, whereas their mortality in the absence of treatment is 25%.
Lung, venous and (simplified) cardiac ultrasound is associated with improved diagnostic performance in ED. However, no ultrasound algorithm dedicated to emergency physicians has been formally validated. The Blue Protocol (Lichtenstein et al., Chest 2008) has been validated in intensive care patients with very different phenotypes than those admitted to the ED. Pivetta et al. (Chest 2015) proposed an algorithm focused solely for the diagnosis of heart failure, thus not providing a diagnosis for all the other causes of dyspnea in ED. Finally, Zanbonetti et al. (Chest 2017) proposed an "unguided" ultrasound use, notably integrating inferior vena cava evaluation. However, measuring the inferior vena cava is difficult at the start of ED management when patients are in acute respiratory distress.
Detailed description
The investigators aim to assess the feasibility and accuracy of a new pragmatic and original ultrasound algorithm adapted for acute dyspnea diagnosis in the emergency department.
This primary objective of this prospective multicenter study is to assess the diagnostic accuracy of an ultrasound algorithm (EMERALD-US) dedicated to emergencies using lung, cardiac and vascular ultrasound for the 3 main dyspnea causes (heart failure, pneumonia and obstructive pulmonary disease exacerbation) in patients with acute non-traumatic dyspnea managed in the emergency department. Ultrasound exams will be blindly read by a centralized core laboratory after the standardized acquisition of all exams by a physician not involved in the care of patients in the ED. The main discharge diagnosis from initial hospitalization (heart failure, pneumonia and obstructive pulmonary disease exacerbation) will be adjudicated by a college of 3 senior physicians (emergency physician, cardiologist and internist) blinded to the use of ultrasound in the ED.
The secondary objectives of the study are to:
A/ Assess the feasibility of the ultrasound algorithm (EMERALD-US) in emergency departments.
B/ Assess the association between the diagnosis obtained from the ultrasound algorithm (EMERALD-US) and the results of additional (laboratory and radiological exams.
C/ Assess the diagnostic accuracy of the ultrasound algorithm (EMERALD-US) for less frequent dyspnea causes (pulmonary embolism, pleural effusion).
D/ Assess, the diagnostic accuracy of clinical (including BREST and PREDICA score), laboratory and radiological variables.
E/ Assess, the improvement in diagnosis accuracy with the ultrasound algorithm (EMERALD-US) on top of the diagnostic accuracy of clinical, laboratory and radiological exams.
F/ Assess the association between misdiagnosis (without using ultrasound) and survival at D30.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute non-traumatic dyspnea patients | Other | Procedure: Ultrasound algorithm (EMERALD-US)Patients with acute non-traumatic dyspnea managed in the emergency department to assess the diagnostic accuracy of an ultrasound algorithm (EMERALD-US) dedicated to emergencies using lung, cardiac and vascular ultrasound for the 3 main dyspnea causes (heart failure, pneumonia and obstructive pulmonary disease exacerbation) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women ≥ 50 years old
- Patients with non-traumatic acute dyspnea managed in the emergency department
- Patients affiliated with a social security system
Key exclusion criteria (8 listed)
- Patients in cardiac arrest
- Patients in persistent shock
- Patients with impaired consciousness (Glasgow Score<9)
- Patients with a history of thoracic surgery or pulmonary fibrosis
- Dementia
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 |
|---|---|---|
| Ultrasound algorithm (EMERALD-US)Ultrasound algorithm EMERALD-US is an dedicated to emergencies using lung, cardiac and vascular ultrasound for the 3 main dyspnea causes (heart failure, pneumonia and obstructive pulmonary disease exacerbation) in patients with acute non-traumatic dyspnea managed in the emergency department. The ultrasounds will be performed within first hour after first medical contact in emergency department by another emergency physician not in charge of the patient. The ultrasound results will be not shared with the emergency physician in charge of the patient. | Procedure or surgery | Acute non-traumatic dyspnea patients |
Primary outcome
Main discharge diagnosis (heart failure, pneumonia and obstructive pulmonary disease exacerbation)
Time frame: an average of 2 weeks (from date of admission in the emergency department until the date of hospitalization discharge)
Main discharge diagnosis (heart failure, pneumonia and obstructive pulmonary disease exacerbation) adjudicated by a college of 3 senior physicians (emergency physician, cardiologist and internist) blinded to the use of ultrasound in the emergency department
10 secondary outcomes
Duration of the ultrasound examination
Time frame: up to 30 minutes
Proportion of complete realization of the ultrasound algorithm
Time frame: up to 30 minutes
Diagnosis given by the algorithm after core-lab reading of the blinded ultrasound compared to the diagnosis provided by the emergency physician based on the EMERALD algorithm in the emergency department
Time frame: At baseline
Patient management time in the emergency department
Time frame: An average of 24 hours (Time between the time of entry to the emergency department and the time of discharge).
Brain Natriuretic Peptide (BNP) or N-terminal pro-brain natriuretic peptide concentration
Time frame: At admission in the emergency department
C Reactive protein and procalcitonin concentration,
Time frame: At admission in the emergency department
D-dimer concentration,
Time frame: At admission in the emergency department
Radiological diagnosis (chest X-ray or chest CT).
Time frame: At admission in the emergency department
Main discharge diagnosis including combined diagnosis (e.g. heart failure and pneumonia) from initial hospitalization adjudicated by a college of 3 senior physicians
Time frame: An average of 2 weeks (from date of admission in the emergency department until the date of discharge)
All-cause mortality at D30.
Time frame: At 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 16 Jan 2025.
- Derived from this study: PubMed 40784781Jaeger D, Duchanois C, Duarte K, Lepage X, Merckle L, Bassand A, Buessler A, Chauvin A, Bokobza J, Penine A, Giacomin G, Brossard C, Girerd N, Chouihed T. Performance of an ultrasound diagnostic algorithm for acute dyspneic patients in the emergency department: an EMERALD-US protocol. BMJ Open. 2025 Aug 10;15(8):e101432. doi: 10.1136/bmjopen-2025-101432.
- Individual participant dataSharing planned: No
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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.
Nicolas GIRERD, MD PhD contact
Tahar CHOUIHED, MD principal investigator
Central Hospital, CHRU de Nancy, France
Nicolas GIRERD, MD PhD study chair
CHRU de Nancy, France
Patrick ROSSIGNOL, MD PhD study chair
CHRU de Nancy, France
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound algorithm (EMERALD-US) in people with Dyspnea, run by CHOUIHED Tahar at 7 sites 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 3 inclusion and 8 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 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Tahar CHOUIHED, MD ((0)3 83 85 14 96 ext. +33, t.chouihed@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main discharge diagnosis (heart failure, pneumonia and obstructive pulmonary disease exacerbation) (time frame: an average of 2 weeks (from date of admission in the emergency department until the date of hospitalization discharge)). 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 NCT03691857, 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 16 Jan 2025.