NCT03691857 Feasibility and Accuracy of an Ultrasound Algorithm for Acute Dyspnea Diagnosis in the Emergency Department
| NCT ID | NCT03691857 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CHOUIHED Tahar |
| Condition | Dyspnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 225 participants |
| Start Date | 2020-12-14 |
| Primary Completion | 2025-03-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 225 participants in total. It began in 2020-12-14 with a primary completion date of 2025-03-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The management of chest pain has revolutionized its prognosis, primarily by improving urgent diagnosis of myocardial infarction. Currently, acute dyspnea is twice as frequent as chest pain and its associated mortality is much higher (16% of acute dyspnea admitted to emergency departments (ED) ). Inappropriate treatment of acute dyspnea in the ED is frequent (30%) and is associated with a tripling of intra-hospital mortality after adjustment for confounding factors (2.83, IC 1.48 to 5.41, p=0.002). Other elements have also highlighted the importance of a quick and appropriate acute dyspnea diagnosis: * The 2015 European Guidelines on acute heart failure emphasize the need for appropriate treatment within 90 minutes after the first medical contact. * Inadequate treatment of chronic bronchitis decompensation is associated with a doubling of intra-hospital mortality. * An initiation of antibiotic treatment within 4 hours of admission for pneumonia is recommended. * 30% of pulmonary embolisms are not diagnosed during the initial emergency department visit, whereas their mortality in the absence of treatment is 25%. Lung, venous and (simplified) cardiac ultrasound is associated with improved diagnostic performance in ED. However, no ultrasound algorithm dedicated to emergency physicians has been formally validated. The Blue Protocol (Lichtenstein et al., Chest 2008) has been validated in intensive care patients with very different phenotypes than those admitted to the ED. Pivetta et al. (Chest 2015) proposed an algorithm focused solely for the diagnosis of heart failure, thus not providing a diagnosis for all the other causes of dyspnea in ED. Finally, Zanbonetti et al. (Chest 2017) proposed an "unguided" ultrasound use, notably integrating inferior vena cava evaluation. However, measuring the inferior vena cava is difficult at the start of ED management when patients are in acute respiratory distress.
Eligibility Criteria
Inclusion Criteria: * Men and women ≥ 50 years old * Patients with non-traumatic acute dyspnea managed in the emergency department * Patients affiliated with a social security system Exclusion Criteria: * Patients in cardiac arrest * Patients in persistent shock * Patients with impaired consciousness (Glasgow Score\<9) * Patients with a history of thoracic surgery or pulmonary fibrosis * Dementia * Patients with Acute Coronary Syndrome with ST elevation * Known current pregnancy * Patients under guardianship, trusteeship or legal protection
Contact & Investigator
Tahar CHOUIHED, MD
PRINCIPAL INVESTIGATOR
Central Hospital, CHRU de Nancy, France
Frequently Asked Questions
Who can join the NCT03691857 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Dyspnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03691857 currently recruiting?
Yes, NCT03691857 is actively recruiting participants. Contact the research team at t.chouihed@chru-nancy.fr for enrollment information.
Where is the NCT03691857 trial being conducted?
This trial is being conducted at Châlons-en-Champagne, France, Eaubonne, France, Nancy, France, Paris, France and 3 additional locations.
Who is sponsoring the NCT03691857 clinical trial?
NCT03691857 is sponsored by CHOUIHED Tahar. The principal investigator is Tahar CHOUIHED, MD at Central Hospital, CHRU de Nancy, France. The trial plans to enroll 225 participants.