NCT07104578

Brief Summary

Dyspnea is a subjective symptom perceived by the patient as a sensation of "breathing discomfort", "suffocation", "lack of air" or "difficulty inhaling or exhaling". It is a frequent reason for calling for help (8% of calls). The most seriously ill patients require the dispatch of specialized teams capable of initiating respiratory support in order to reduce the morbidity and mortality of these patients. In France, these teams are medicalized by an emergency physician within the Mobile Emergency Resuscitation Services (SMUR). This is only rarely the case outside France, where specialized paramedical teams ("advanced life support paramedic teams") can be dispatched. Apart from their role of initiating possible respiratory support, these teams (SMUR or paramedics) can initiate a diagnostic approach and therapeutics related to the suspected origin of dyspnea. However, there are many diagnoses that can cause dyspnea, and the diagnostic process can be complex. The most common diagnoses described in the prehospital population are: bacterial pneumonia, acute heart failure, and exacerbation of COPD or asthma or pulmonary embolism. Each of these diagnoses requires specific drug treatment, guided by international recommendations. Inappropriate treatment of these pathologies (overtreatment or undertreatment) is common and associated with excess intrahospital mortality. Pleuropulmonary ultrasound (PUS) has shown very interesting diagnostic performance in the intrahospital setting for diagnoses of interest in dyspnea. This performance also appears good in the prehospital setting. In the intrahospital setting, PUS appears to improve the diagnostic approach and appropriate treatments for dyspnea. In the prehospital setting, however, data on this subject are scarce or of limited quality according to the most recent meta-analysis, while the use of this technique is becoming increasingly common in standardized patient care. In addition, the most recent work on the subject included patients in a non-medicalized prehospital system. The use of PUS would allow paramedics to increase the rate of appropriate treatment from 14% to 53%. However, the rate of appropriate treatment expected by a medicalized team is expected to be 62%, and the diagnostic performance of physicians in PUS is probably higher than that of paramedics. These data must therefore be consolidated in a French system before being the subject of higher-level recommendations. The systematic use of PUS during prehospital engagement of a SMUR for dyspnea also may improves the rate of appropriate treatment, even in a context of medicalization of the initial care of patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress54%
Aug 2025Feb 2027

First Submitted

Initial submission to the registry

July 7, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

July 7, 2025

Last Update Submit

September 22, 2025

Conditions

Keywords

dyspneapleuropulmonary ultrasounddiagnostic

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the impact of pre-hospital EPP on the rate of appropriate treatments offered.

    Therapeutic adequacy at the final diagnosis before and after completion of the PUS. Therapeutic adequacy and inadequacy are defined based on the treatment proposed before and after completion of the PUS, compared to the final diagnosis at hospital discharge. The following are considered inadequate: * In a patient on a pulmonary embolism (PE): * Prescribing beta-agonists or antibiotics (unless septic) * Not prescribing diuretics and nitrates if SBP \> 140 mmHg * In a patient with decompensated COPD: * Prescribing diuretics * Not prescribing beta-agonists * In a patient with a pulmonary infection: * Prescribing diuretics * Not prescribing antibiotics * In a patient with a pulmonary embolism: * Not prescribing curative doses of anticoagulation In the case of multiple diagnoses (e.g., transfer to a PE due to pneumonia), only treatments that are inadequate for each diagnosis will be considered inadequate.

    from the inclusion of the patient until the time he or she leaves the hospital, assessed up 52 weeks, whichever came first

Secondary Outcomes (1)

  • Evaluation of the impact of PUS carried out in prehospital settings on the diagnostic process.

    from the inclusion of the patient until the time he or she leaves the hospital, assessed up 52 weeks, whichever came first

Study Arms (1)

patients with respiratory distress

patients in respiratory distress treated by the SMUR

Diagnostic Test: Pleuropulmonary ultra sound

Interventions

pleuropulmonary ultrasound performed as part of the treatment

patients with respiratory distress

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients admitted to the emergency room for dyspnea

You may qualify if:

  • Adult patient
  • Treated by a prehospital emergency medical service
  • For dyspnea with signs of severity, the following are the following:
  • SpO2 \< 90% in AA or O2 required to maintain SpO2 ≥ 90% and
  • RR \> 25 cycles/min

You may not qualify if:

  • Need for immediate intubation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pôle Médecine d'Urgence Hôpital Purpan Pavillon Louis Lareng Place Docteur Baylac

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

DyspneaDisease

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Pauline Marchetto, PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pauline Marchetto, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
52 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2025

First Posted

August 5, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations