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

ConditionAcute Dyspnea
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: no-ultrasound during SMUR interventions.No intervention 0 interventions
Group B: Intervention phase: use of ultrasound during SMUR interventions.Experimental treatment 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

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Central Hospital, Nancy, France

Lead sponsor

Direction Générale de l'Offre de Soins

Collaborator

This trial is not recruiting at the moment. You can still explore other options: