Feasibility and Accuracy of an Ultrasound Algorithm for Acute Dyspnea Diagnosis in the Emergency Department
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Dyspnea
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 50 years and 125 years
- Gender
- Both males and females
Description
The investigators aim to assess the feasibility and accuracy of a new pragmatic and original ultrasound algorithm adapted for acute dyspnea diagnosis in the emergency department. This primary objective of this prospective multicenter study is to assess the diagnostic accuracy of an ultrasound algori...
The investigators aim to assess the feasibility and accuracy of a new pragmatic and original ultrasound algorithm adapted for acute dyspnea diagnosis in the emergency department. This primary objective of this prospective multicenter study is to assess the diagnostic accuracy of an ultrasound algorithm (EMERALD-US) dedicated to emergencies using lung, cardiac and vascular ultrasound for the 3 main dyspnea causes (heart failure, pneumonia and obstructive pulmonary disease exacerbation) in patients with acute non-traumatic dyspnea managed in the emergency department. Ultrasound exams will be blindly read by a centralized core laboratory after the standardized acquisition of all exams by a physician not involved in the care of patients in the ED. The main discharge diagnosis from initial hospitalization (heart failure, pneumonia and obstructive pulmonary disease exacerbation) will be adjudicated by a college of 3 senior physicians (emergency physician, cardiologist and internist) blinded to the use of ultrasound in the ED. The secondary objectives of the study are to: A/ Assess the feasibility of the ultrasound algorithm (EMERALD-US) in emergency departments. B/ Assess the association between the diagnosis obtained from the ultrasound algorithm (EMERALD-US) and the results of additional (laboratory and radiological exams. C/ Assess the diagnostic accuracy of the ultrasound algorithm (EMERALD-US) for less frequent dyspnea causes (pulmonary embolism, pleural effusion). D/ Assess, the diagnostic accuracy of clinical (including BREST score), laboratory and radiological variables. E/ Assess, the improvement in diagnosis accuracy with the ultrasound algorithm (EMERALD-US) on top of the diagnostic accuracy of clinical, laboratory and radiological exams. F/ Assess the association between misdiagnosis (without using ultrasound) and survival at D30.
Tracking Information
- NCT #
- NCT03691857
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Tahar CHOUIHED, MD Central Hospital, CHRU de Nancy, France Study Chair: Nicolas GIRERD, MD PhD CHRU de Nancy, France Study Chair: Patrick ROSSIGNOL, MD PhD CHRU de Nancy, France