Study Summary
Rationale
Pneumonia is a common and serious disease that requires early and accurate diagnosis. Lung ultrasound (LUS) is a safe, inexpensive, and reliable method to identify pneumonia at the bedside. The current standard method, the six-point Bedside Lung Ultrasound in Emergency (BLUE) protocol, requires experience to correctly locate and interpret fixed scanning points, limiting its broader use. A simplified sweep-based method, using continuous probe movements over the chest, may reduce operator dependency while maintaining diagnostic accuracy.
Objective
The primary objective is to compare the diagnostic accuracy of the simplified sweep-based protocol with the standard BLUE protocol for identifying pneumonia. Secondary objectives are to assess (1) agreement in LUS A, B, C and E- patterns between both methods, (2) examination time and feasibility of the simplified method, (3) AI development to detect pneumonia via LUS A, B, C and E- patterns, and (4) To compare the diagnostic accuracy of both the simplified sweep-based protocol and the validated BLUE protocol with chest X-ray (CXR) and/or gold standard computed tomography (CT) in diagnosing pneumonia.
Hypothesis
The simplified sweep-based method provides diagnostic accuracy comparable to the standard six-point BLUE protocol for detecting abnormalities consistent with pneumonia.
Study design
This is a single-centre, prospective, observational study conducted at Amsterdam UMC, location Amsterdam Medical Centre (AMC). Adult patients (≥18 years) admitted to the emergency department (ED) or intensive care unit (ICU) with respiratory insufficiency and/or suspected pneumonia will be included. Only awake, non-sedated patients who can sit or be positioned semi-upright, allowing posterior lung scanning, are eligible.
Intervention
Lung ultrasound following the BLUE-protocol and a 4-sweep protocol.
Main study parameters/endpoints
The primary study parameter is the diagnostic accuracy (sensitivity, specificity, positive and negative predictive values) of the sweep-based method compared to the standard BLUE protocol.
Call for centers
Study Team
Steering committee | Amsterdam UMC Dr. Pieter-Roel Tuinman
Steering committee | DelftAI
Registration of the ALERT study at Overzicht van Medisch-wetenschappelijk Onderzoek in Nederland (OMON).
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