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Starting soon Not applicable

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

NCT07852364 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2027-01-10
Last updated
2026-10-01

Condition(s) studied

Acute Dyspnea

Investigational drug(s) / intervention(s)

Ultrasound pre-hospital care

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

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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: * 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.

Primary outcome measure(s)

  • Score for appropriate treatments administered during the prehospital emergency medical team (SMUR) intervention. — 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.

Trial sites (11)

FacilityCityRegionStatus
Centre Hospitalier d'Argenteuil Argenteuil France
CHU Clermont-Ferrand, Hôpital Gabriel Montpied Clermont-Ferrand France
Centre Hospitalier Annecy Genevois Épagny France
CHU Lille Lille France
Groupe Hospitalier de la Région de Mulhouse et Sud Alsace - Hôpital Emile Muller. Mulhouse France
Centre Hospitalier Régional Universitaire de Nancy Nancy France
Hôpital Lariboisière AP-HP, Paris. Paris France
Hôpital de la Pitié Salpêtrière - AP-HP Paris France
CHU de Poitiers Poitiers France
CHU de Reims Reims France
CHU Rouen - Hôpital Charles Nicolle Rouen France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07852364 on ClinicalTrials.gov ↗ ← All trials in France