DyspneaLU-SMURNCT07104578
Evaluation of the Impact of Pleuropulmonary Ultrasound on the Diagnosis of Dyspnea
An observational study of Dyspnea, run by University Hospital, Toulouse at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- Pleuropulmonary ultra sound
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2025to 1 Feb 2027
- How long will I take part?
- 52 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted to the emergency room for dyspnea
Who may be able to join
- 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
Who cannot join
- Opposition to inclusion
- Need for immediate intubation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Pôle Médecine d'Urgence Hôpital Purpan Pavillon Louis Lareng Place Docteur Baylac
Toulouse, 31059
Emeline Muller, 05 61 77 87 07 ext. 33, muller.E@chu-toulouse.Fr
Pauline Marchetto, PhD
About this study
Official title: Evaluation of the Impact of Pleuropulmonary Ultrasound Performed by the Emergency Physician on the Diagnosis of Dyspnea in the Prehospital Setting
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.
- Conditions
- Dyspnea
- Being tested
- Pleuropulmonary ultra sound
- Keywords
- dyspnea, pleuropulmonary ultrasound, diagnostic
- Medical subject headings
- Dyspnea, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleuropulmonary ultra soundDiagnostic test
pleuropulmonary ultrasound performed as part of the treatment
| Study group | Role | What they receive |
|---|---|---|
| patients with respiratory distress | patients in respiratory distress treated by the SMUR Receives: Diagnostic Test: Pleuropulmonary ultra sound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
correct diagnosis(es) before and after PUS compared to the final diagnosis upon discharge from hospital.
Measured: from the inclusion of the patient until the time he or she leaves the hospital, assessed up 52 weeks, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Aug 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 52 Weeks
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline Marchetto, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104578
- Sponsor's protocol ID
- RC31/25/0219
- Other IDs
- ID-RCB
- Acronym
- LU-SMUR
- Status last verified
- Sep 2025
- First submitted
- 7 Jul 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Pleuropulmonary Ultrasound Performed by the Emergency Physician on the Diagnosis of Dyspnea in the Prehospital Setting
- ClinicalTrials.gov ID
- NCT07104578
- Acronym / sponsor ID
- LU-SMUR / RC31/25/0219
- Conditions
- Dyspnea
- Keywords
- dyspnea, pleuropulmonary ultrasound, diagnostic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 52 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with respiratory distress | – | Diagnostic Test: Pleuropulmonary ultra soundpatients in respiratory distress treated by the SMUR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted to the emergency room for dyspnea
Key inclusion criteria (5 listed)
- Adult patient
- Treated by a prehospital emergency medical service
- For dyspnea with signs of severity, the following are the following:
Key exclusion criteria (2 listed)
- Opposition to inclusion
- Need for immediate intubation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pleuropulmonary ultra soundpleuropulmonary ultrasound performed as part of the treatment | Diagnostic test | patients with respiratory distress |
Primary outcome
Evaluation of the impact of pre-hospital EPP on the rate of appropriate treatments offered.
Time frame: from the inclusion of the patient until the time he or she leaves the hospital, assessed up 52 weeks, whichever came first
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.
1 secondary outcome
Evaluation of the impact of PUS carried out in prehospital settings on the diagnostic process.
Time frame: from the inclusion of the patient until the time he or she leaves the hospital, assessed up 52 weeks, whichever came first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pauline Marchetto, PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pauline Marchetto, PHD (0561772579 ext. 33, marchetto.p@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the impact of pre-hospital EPP on the rate of appropriate treatments offered. (time frame: from the inclusion of the patient until the time he or she leaves the hospital, assessed up 52 weeks, whichever came first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.