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Not yet recruitingNCT07852364IMICU2-DyspneaUpdated Oct 1, 2026

Implementation of Mobile Intensive Care Unit Ultrasound Based Management for Acute Dyspnea

An interventional study of Ultrasound pre-hospital care in Acute Dyspnea, sponsored by Central Hospital, Nancy, France. Not yet recruiting at 11 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Diagnostic

Updated Oct 1, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
800
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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).

02

Conditions studied

  • Acute Dyspnea

Keywords

  • primary care
  • acute dyspnea
  • healthcare organisation
  • strategy
  • implementation
  • ultrasound
03

In context

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

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

04

Who can participate

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

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

Study arms

  • No intervention
    no-ultrasound during SMUR interventions.

    Standard management of acute dyspnea by the SMUR.

  • Experimental
    Intervention phase: use of ultrasound during SMUR interventions.

    the period during which ultrasound is being implemented for the management of acute dyspnea by the SMUR team.

    Diagnostic Test: Ultrasound pre-hospital care

Interventions

  • Diagnostic testUltrasound pre-hospital care

    Use of Ultrasound to guide pre-hospital care for the management of acute dyspnea by the Mobile Emergency Medical Service (SMUR).

06

What researchers measure

Primary outcomes

  1. Score for appropriate treatments administered during the prehospital emergency medical team (SMUR) 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.

    Time frame: Baseline (at the time of the SMUR's intervention).

Secondary outcomes

  1. 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).

  2. Clinical factors evaluated: all-cause mortality.

    Time frame: At 30 days, 90 days and 5 years.

  3. Clinical factors evaluated: readmission for acute dyspnea (following the comittee's decision).

    Time frame: At 30 days, 90 days and 5 years.

  4. Clinical factors evaluated: consultations with general practitioners.

    Number of consultations with general practitioners.

    Time frame: At 30 days, 90 days and 5 years.

  5. Clinical factors evaluated: consultations with specialists.

    Number of consultations with specialists.

    Time frame: At 30 days, 90 days and 5 years.

  6. Clinical factors evaluated: prescriptions for medication.

    Number of prescriptions for medication dispensed.

    Time frame: At 30 days, 90 days and 5 years.

  7. Clinical factors evaluated: clinical laboratory tests.

    Number of clinical laboratory tests carried out.

    Time frame: At 30 days, 90 days and 5 years.

  8. Clinical factors evaluated: readmissions for causes other than acute dyspnea.

    Time frame: At 30 days, 90 days and 5 years.

  9. 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).

  10. 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).

    Time frame: Baseline (at the time of the SMUR's intervention).

  11. 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).

  12. 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.

    Time frame: Baseline.

  13. 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.

  14. 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.

  15. 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).

    Time frame: At 12 months.

07

Study locations

11 sites
  • Centre Hospitalier d'Argenteuil
    Argenteuil, 95100, France
  • CHU Clermont-Ferrand, Hôpital Gabriel Montpied
    Clermont-Ferrand, 63000, France
  • Centre Hospitalier Annecy Genevois
    Épagny, 74370, France
  • CHU Lille
    Lille, 59037, France
  • Groupe Hospitalier de la Région de Mulhouse et Sud Alsace - Hôpital Emile Muller.
    Mulhouse, 68100, France
  • Centre Hospitalier Régional Universitaire de Nancy
    Nancy, France
  • Hôpital Lariboisière AP-HP, Paris.
    Paris, 75010, France
  • Hôpital de la Pitié Salpêtrière - AP-HP
    Paris, 75013, France
  • CHU de Poitiers
    Poitiers, 85021, France
  • CHU de Reims
    Reims, 51100, France
  • CHU Rouen - Hôpital Charles Nicolle
    Rouen, 76031, France
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07852364
Lead sponsor
Central Hospital, Nancy, France
Collaborators
Direction Générale de l'Offre de Soins
Responsible party
Pr. Nicolas GIRERD (Professor of Medicine (PU-PH), Central Hospital, Nancy, France) — Principal investigator
First posted
Oct 1, 2026
Start date
Jan 10, 2027 (estimated)
Primary completion
Mar 10, 2028 (estimated)
Completion
Mar 10, 2033 (estimated)
Last update
Oct 1, 2026

Study contacts

Nicolas GIRERD
Contact
n.girerd@chru-nancy.fr
+33 03 83 15 73 24
Tahar Chouihed
Contact
T.CHOUIHEDMAHJOUB@chru-nancy.fr
+33 03 83 85 25 76
Nicolas GIRERD
principal investigator · CHRU de Nancy, France

Oversight

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

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