Acute DyspneaIMICU2-DyspneaNCT07852364
Implementation of Mobile Intensive Care Unit Ultrasound Based Management for Acute Dyspnea
A study testing Ultrasound pre-hospital care in people with Acute Dyspnea, run by Central Hospital, Nancy, France at 11 sites in France.
Trial summary
This multicentre, cluster-randomised, stepped-wedge clinical trial aims to assess whether an intervention designed to implement an ultrasound-guided pre-hospital care pathway for the management of acute dyspnea would improve the effectiveness and efficiency of the mobile emergency medical service (SMUR) compared with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Dyspnea
- What is being tested?
- Ultrasound pre-hospital care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 11 sitesFrance
- Study dates
- 10 Jan 2027to 10 Mar 2033
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥ 18 years olds
- Patients with non-traumatic acute dyspnea requiring intervention and management by an emergency medical services team
- Patient receiving oxygen during emergency medical services treatment
- Patients affiliated with a social security system
Who cannot join
- Patient for whom the reason for intervention is chest pain or shock
- Patient with impaired consciousness requiring immediate intubation
- Patients under guardianship, trusteeship or legal protection
- Patients deprived of their liberty by judicial or administrative decision, persons undergoing psychiatric care
- Patients who objects to the processing of their personal data for study-related quality control, monitoring, audit, or regulatory compliance purposes.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites
Centre Hospitalier d'Argenteuil
Argenteuil, 95100
CHU Clermont-Ferrand, Hôpital Gabriel Montpied
Clermont-Ferrand, 63000
Centre Hospitalier Annecy Genevois
Épagny, 74370
CHU Lille
Lille, 59037
Groupe Hospitalier de la Région de Mulhouse et Sud Alsace - Hôpital Emile Muller.
Mulhouse, 68100
Centre Hospitalier Régional Universitaire de Nancy
Nancy
Hôpital Lariboisière AP-HP, Paris.
Paris, 75010
Hôpital de la Pitié Salpêtrière - AP-HP
Paris, 75013
CHU de Poitiers
Poitiers, 85021
CHU de Reims
Reims, 51100
CHU Rouen - Hôpital Charles Nicolle
Rouen, 76031
About this study
Official title: Implementation of Mobile Intensive Care Unit Ultrasound Based Management for Acute Dyspnea: A Stepped Wedge Cluster Randomized Controlled Trial - IMICU2 Dyspnea
This multicentre, cluster-randomised, stepped-wedge clinical trial aims to assess whether an intervention designed to implement an ultrasound-guided pre-hospital care pathway for the management of acute dyspnea would improve the effectiveness and efficiency of the mobile emergency medical service (SMUR) compared with standard care.
The order in which centres switch to the intervention (use of ultrasound) will be randomized. The study will begin with an initial 2-month period during which no centre will use ultrasound (standard care). Thereafter, two centers will switch to the intervention phase, and every two months, a further two centres will in turn move into the intervention phase. By the end of the study, all centres will have used ultrasound for at least 2 months.
Read more
A total of 800 adults patients treated for acute dyspnea by the SMUR and meeting the inclusion criteria will be enrolled. Each patient's management will be determined by the study phase in effect at their centre at the time of enrolment (control phase without ultrasound or intervention phase with ultrasound).
The appropriateness of treatments administered during SMUR interventions will be compared between the period with ultrasound (intervention phase) and the period without ultrasound (control pahse).
- Conditions
- Acute Dyspnea
- Being tested
- Ultrasound pre-hospital care
- Keywords
- primary care, acute dyspnea, healthcare organisation, strategy, implementation, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound pre-hospital careDiagnostic test
Use of Ultrasound to guide pre-hospital care for the management of acute dyspnea by the Mobile Emergency Medical Service (SMUR).
| Study group | Role | What they receive |
|---|---|---|
| no-ultrasound during SMUR interventions. | No intervention | Standard management of acute dyspnea by the SMUR. |
| Intervention phase: use of ultrasound during SMUR interventions. | Experimental | the period during which ultrasound is being implemented for the management of acute dyspnea by the SMUR team. Receives: Diagnostic Test: Ultrasound pre-hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score for appropriate treatments administered during the prehospital emergency medical team (SMUR) intervention.
- This outcome ranges from 0 to 1 (0 = completely inappropriate treatment; 1 = appropriate and effective/minimal treatment). 2) This outcome requires a review of the final diagnosis of acute dyspnea cases treated by the SMUR, as well as an assessment of whether each treatment administered in the SMUR ambulance was appropriate. This review will be conducted by a multidisciplinary team without knowledge of the randomization group.
Measured: Baseline (at the time of the SMUR's intervention).
Secondary outcomes (15)
Clinical factors evaluated: diagnosis made in the SMUR ambulance, considered to be consistent with the final diagnosis upon admission.
Measured: Baseline (at the time of the SMUR's intervention).
Clinical factors evaluated: all-cause mortality.
Measured: At 30 days, 90 days and 5 years.
Clinical factors evaluated: readmission for acute dyspnea (following the comittee's decision).
Measured: At 30 days, 90 days and 5 years.
Clinical factors evaluated: consultations with general practitioners.
Number of consultations with general practitioners.
Measured: At 30 days, 90 days and 5 years.
Clinical factors evaluated: consultations with specialists.
Number of consultations with specialists.
Measured: At 30 days, 90 days and 5 years.
Clinical factors evaluated: prescriptions for medication.
Number of prescriptions for medication dispensed.
Measured: At 30 days, 90 days and 5 years.
Clinical factors evaluated: clinical laboratory tests.
Number of clinical laboratory tests carried out.
Measured: At 30 days, 90 days and 5 years.
Clinical factors evaluated: readmissions for causes other than acute dyspnea.
Measured: At 30 days, 90 days and 5 years.
Institutional elements assessed : time taken for the SMUR to initiate appropriate pre-hospital treatment.
Measured: Baseline (at the time of the SMUR's intervention).
Institutional elements assessed : duration of SMUR interventions.
This outcome is defined as the time interval between the arrival of the SMUR team on scene and the patient's transfer to the next level of care (emergency department or specialized unit).
Measured: Baseline (at the time of the SMUR's intervention).
Institutional elements assessed : proportion of patients admitted directly (without going through the emergency department) to specialzed units (primarily cardiology, pulmonology, cardiac or respiratory intensive care, and critical care)
Measured: Baseline (at the time of the SMUR's intervention).
Institutional elements assessed : hospital length of stay following intervention by the SMUR.
Hospital length of stay is defined as the time interval from the end of SMUR care to hospital discharge either to the patient's home or to an outpatient facility.
Measured: Baseline.
Factors relevant to an implementation analysis: the proportion of ultrasound scans performed by the SMUR team in cases of acute dyspnea during the "ultrasound" period.
Measured: Baseline.
Factors relevant to an implementation analysis: the level of agreement between the interpretation of ultrasound images by staff trained at the completion of their initial training and at 12 months, and those of an expert reference standard.
Measured: Baseline (initial training) and at 12 months.
Factors relevant to an implementation analysis: the satisfaction of emergency doctors with the implementation of the ultrasound algorithm.
The satisfaction will be assessed using a Likert scale (ranging from 1 to 5, with "1" representing the worst result and "5" the best).
Measured: At 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start10 Jan 2027 (estimated)
- Primary completion10 Mar 2028 (estimated)
- Study completion10 Mar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DyspneaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Multicentre, cluster-randomised, stepped-wedge controlled study : Two period are compared the period with ultrasound (intervention phase) and the period without ultrasound (control phase). The order in which centres switch to the intervention (use of ultrasound) will be randomized, the randomisation concernes centres not patient. The study will begin with an initial 2-month period during which no centre will use ultrasound (standard care). Thereafter, two centers will switch to the intervention phase, and every two months, a further two centres will in turn move into the intervention phase. By the end of the study, all centres will have used ultrasound for at least 2 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Principal investigator, Pr. Nicolas GIRERD, Central Hospital, Nancy, France
- Investigators
- Nicolas GIRERD, Principal investigator, CHRU de Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852364
- Sponsor's protocol ID
- N°ID-RCB : 2025-A01397-42
- Acronym
- IMICU2-Dyspnea
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Mobile Intensive Care Unit Ultrasound Based Management for Acute Dyspnea: A Stepped Wedge Cluster Randomized Controlled Trial - IMICU2 Dyspnea
- ClinicalTrials.gov ID
- NCT07852364
- Acronym / sponsor ID
- IMICU2-Dyspnea / N°ID-RCB : 2025-A01397-42
- Conditions
- Acute Dyspnea
- Keywords
- primary care, acute dyspnea, healthcare organisation, strategy, implementation, ultrasound
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- 10 Jan 2027 (estimated)
- Primary completion
- 10 Mar 2028 (estimated)
- Study completion
- 10 Mar 2033 (estimated)
- First posted
- 1 Oct 2026 (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.
This multicentre, cluster-randomised, stepped-wedge clinical trial aims to assess whether an intervention designed to implement an ultrasound-guided pre-hospital care pathway for the management of acute dyspnea would improve the effectiveness and efficiency of the mobile emergency medical service (SMUR) compared with standard care.
The order in which centres switch to the intervention (use of ultrasound) will be randomized. The study will begin with an initial 2-month period during which no centre will use ultrasound (standard care). Thereafter, two centers will switch to the intervention phase, and every two months, a further two centres will in turn move into the intervention phase. By the end of the study, all centres will have used ultrasound for at least 2 months.
A total of 800 adults patients treated for acute dyspnea by the SMUR and meeting the inclusion criteria will be enrolled. Each patient's management will be determined by the study phase in effect at their centre at the time of enrolment (control phase without ultrasound or intervention phase with ultrasound).
The appropriateness of treatments administered during SMUR interventions will be compared between the period with ultrasound (intervention phase) and the period without ultrasound (control pahse).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentre, cluster-randomised, stepped-wedge controlled study : Two period are compared the period with ultrasound (intervention phase) and the period without ultrasound (control phase). The order in which centres switch to the intervention (use of ultrasound) will be randomized, the randomisation concernes centres not patient. The study will begin with an initial 2-month period during which no centre will use ultrasound (standard care). Thereafter, two centers will switch to the intervention phase, and every two months, a further two centres will in turn move into the intervention phase. By the end of the study, all centres will have used ultrasound for at least 2 months.
| Arm | Type | Receives |
|---|---|---|
| no-ultrasound during SMUR interventions. | No intervention | –Standard management of acute dyspnea by the SMUR. |
| Intervention phase: use of ultrasound during SMUR interventions. | Experimental | Diagnostic Test: Ultrasound pre-hospital carethe period during which ultrasound is being implemented for the management of acute dyspnea by the SMUR team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient ≥ 18 years olds
- Patients with non-traumatic acute dyspnea requiring intervention and management by an emergency medical services team
- Patient receiving oxygen during emergency medical services treatment
- Patients affiliated with a social security system
Key exclusion criteria (5 listed)
- Patient for whom the reason for intervention is chest pain or shock
- Patient with impaired consciousness requiring immediate intubation
- Patients under guardianship, trusteeship or legal protection
- Patients deprived of their liberty by judicial or administrative decision, persons undergoing psychiatric care
- Patients who objects to the processing of their personal data for study-related quality control, monitoring, audit, or regulatory compliance purposes.
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 pre-hospital careUse of Ultrasound to guide pre-hospital care for the management of acute dyspnea by the Mobile Emergency Medical Service (SMUR). | Diagnostic test | Intervention phase: use of ultrasound during SMUR interventions. |
Primary outcome
Score for appropriate treatments administered during the prehospital emergency medical team (SMUR) intervention.
Time frame: Baseline (at the time of the SMUR's intervention).
1) This outcome ranges from 0 to 1 (0 = completely inappropriate treatment; 1 = appropriate and effective/minimal treatment). 2) This outcome requires a review of the final diagnosis of acute dyspnea cases treated by the SMUR, as well as an assessment of whether each treatment administered in the SMUR ambulance was appropriate. This review will be conducted by a multidisciplinary team without knowledge of the randomization group.
15 secondary outcomes
Clinical factors evaluated: diagnosis made in the SMUR ambulance, considered to be consistent with the final diagnosis upon admission.
Time frame: Baseline (at the time of the SMUR's intervention).
Clinical factors evaluated: all-cause mortality.
Time frame: At 30 days, 90 days and 5 years.
Clinical factors evaluated: readmission for acute dyspnea (following the comittee's decision).
Time frame: At 30 days, 90 days and 5 years.
Clinical factors evaluated: consultations with general practitioners.
Time frame: At 30 days, 90 days and 5 years.
Clinical factors evaluated: consultations with specialists.
Time frame: At 30 days, 90 days and 5 years.
Clinical factors evaluated: prescriptions for medication.
Time frame: At 30 days, 90 days and 5 years.
Clinical factors evaluated: clinical laboratory tests.
Time frame: At 30 days, 90 days and 5 years.
Clinical factors evaluated: readmissions for causes other than acute dyspnea.
Time frame: At 30 days, 90 days and 5 years.
Institutional elements assessed : time taken for the SMUR to initiate appropriate pre-hospital treatment.
Time frame: Baseline (at the time of the SMUR's intervention).
Institutional elements assessed : duration of SMUR interventions.
Time frame: Baseline (at the time of the SMUR's intervention).
Institutional elements assessed : proportion of patients admitted directly (without going through the emergency department) to specialzed units (primarily cardiology, pulmonology, cardiac or respiratory intensive care, and critical care)
Time frame: Baseline (at the time of the SMUR's intervention).
Institutional elements assessed : hospital length of stay following intervention by the SMUR.
Time frame: Baseline.
Factors relevant to an implementation analysis: the proportion of ultrasound scans performed by the SMUR team in cases of acute dyspnea during the "ultrasound" period.
Time frame: Baseline.
Factors relevant to an implementation analysis: the level of agreement between the interpretation of ultrasound images by staff trained at the completion of their initial training and at 12 months, and those of an expert reference standard.
Time frame: Baseline (initial training) and at 12 months.
Factors relevant to an implementation analysis: the satisfaction of emergency doctors with the implementation of the ultrasound algorithm.
Time frame: At 12 months.
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 1 Oct 2026.
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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 principal investigator
CHRU de Nancy, France
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound pre-hospital care in people with Acute Dyspnea, run by Central Hospital, Nancy, France at 11 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 Nicolas GIRERD (+33 03 83 15 73 24, n.girerd@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score for appropriate treatments administered during the prehospital emergency medical team (SMUR) intervention. (time frame: Baseline (at the time of the SMUR's intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2026.