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NCT07852364
Implementation of Mobile Intensive Care Unit Ultrasound Based Management for Acute Dyspnea
Conditions: Acute Dyspnea
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 800
Sponsor: Central Hospital, Nancy, France
Location: Centre Hospitalier d'Argenteuil Argenteuil
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07852364). StuddyBuddy aggregates publicly available trial information.