Diagnostic Strategy for Suspected Pulmonary Embolism Based on 4PEPS (SPEED&PEPS)
Pulmonary Embolism
About this trial
This is an interventional diagnostic trial for Pulmonary Embolism focused on measuring Pulmonary Embolism, suspected PE, diagnostic strategy, clinical probability, cluster-randomized trial
Eligibility Criteria
Inclusion Criteria: Admission to an emergency department participating in the study. Suspected PE due to thoracic symptoms (dyspnea, chest pain, or hemoptysis) and/or syncope without any other obvious explanation after clinical examination and possible additional first-line tests (ECG, chest X-ray, or routine lab work-up not including D-dimer test). Free, prior, and informed consent to participate in the study. Exclusion Criteria: Age < 18 years. Known result of a specific diagnostic examination for PE (D-dimer test, thoracic CT angiography, pulmonary scintigraphy, or venous ultrasound of the lower limbs). Hemodynamic instability (systolic blood pressure < 90 mmHg or more than 40 mmHg lower than usual for more than 15 min). Curative dose of anticoagulant in place for more than two days prior to inclusion. Pregnant or parturient patient. Patient in detention by judicial or administrative decision. Patient undergoing compulsory psychiatric treatment. Patient placed under a legal protection measure. Patient incapable of giving free and informed consent.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
No Intervention
Active Comparator
Control group - current practices
Intervention group - 4PEPS strategy
The investigating physicians of the participating centers in the control group will be free to provide care as they see fit. However, a reminder of national and European guidelines for PE management will be given to them and they will have the recommendation to apply a validated strategy. To make it easier, the different scores will be included in the clinical help-decision support software called SPEED. Investigators will be asked to enter data about the included patients directly into SPEED, which will act as the study's electronic case report form (eCRF). A paper version of the CRF will also be available.
Physicians of the participating centers in the intervention group will have the recommendation to apply the 4PEPS strategy. To make it easier to apply, the 4PEPS score will be included in SPEED. Investigators will be asked to enter the information relating to patients included in the study directly into SPEED before performing any testing. Entering these data will enable the 4PEPS score to be calculated automatically and specific recommendations to be provided. A paper version of the CRF will also be available