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

NCT07852364 | Not Yet Recruiting

• 1 other identifier: N°ID-RCB : 2025-A01397-42
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 11

Brief 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).

Conditions

Acute Dyspnea

Keywords

primary care; acute dyspnea; healthcare organisation; strategy; implementation; ultrasound

Outcome Measures

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.

  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.

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

• Clinical factors evaluated: all-cause mortality.

  At 30 days, 90 days and 5 years.

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

  At 30 days, 90 days and 5 years.

• Clinical factors evaluated: consultations with general practitioners.

  At 30 days, 90 days and 5 years.

• Clinical factors evaluated: consultations with specialists.

  At 30 days, 90 days and 5 years.

Study Arms (2)

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.

Diagnostic Test: Ultrasound pre-hospital care

Interventions

Ultrasound pre-hospital care DIAGNOSTIC_TEST

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

Intervention phase: use of ultrasound during SMUR interventions.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Direction Générale de l'Offre de Soins: collaborator

Study Sites (11)

Centre Hospitalier d'Argenteuil

Argenteuil, 95100, France

Location

CHU Clermont-Ferrand, Hôpital Gabriel Montpied

Clermont-Ferrand, 63000, France

Location

Centre Hospitalier Annecy Genevois

Épagny, 74370, France

Location

CHU Lille

Lille, 59037, France

Location

Groupe Hospitalier de la Région de Mulhouse et Sud Alsace - Hôpital Emile Muller.

Mulhouse, 68100, France

Location

Centre Hospitalier Régional Universitaire de Nancy

Nancy, France

Location

Hôpital Lariboisière AP-HP, Paris.

Paris, 75010, France

Location

Hôpital de la Pitié Salpêtrière - AP-HP

Paris, 75013, France

Location

CHU de Poitiers

Poitiers, 85021, France

Location

CHU de Reims

Reims, 51100, France

Location

CHU Rouen - Hôpital Charles Nicolle

Rouen, 76031, France

Location

Study Officials

• Nicolas GIRERD

  CHRU de Nancy, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas GIRERD

CONTACT

+33 03 83 15 73 24; n.girerd@chru-nancy.fr

Tahar Chouihed

CONTACT

+33 03 83 85 25 76; T.CHOUIHEDMAHJOUB@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (PU-PH)

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): January 10, 2027
• Primary Completion (Estimated): March 10, 2028
• Study Completion (Estimated): March 10, 2033
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

FR (11)