Community-acquired Pneumonia Clinical Trial
Official title:
CRP (C-Reactive-Protein) and Pneumonia Biomarkers Stratification for Selectively Addressing Priorities in Thoracic Emergency Ultrasound in Pneumonia
This preliminary study investigates in patients with possible clinical diagnosis of pneumonia, clues and biomarker assessed at Emergency Department (ED) triage, potentially predicting detection of lung consolidation by Thoracic-ultrasound (TUS) and/or by Chest-X-Rays. Cough and high admission CRP levels will be defined according to the cutoff defined by ROC analysis, will be challenged if independently associated with TUS lung consolidation detection High level of the chosen biomarker, and any of the considered symptoms, in otherwise not extremely critical patients (CURB65≤3), should prompt to immediate confirm by TUS, during the physical examination. This may limit the need of further radiological investigations allowing targeted workup.
Chest-X-Rays (CXR), Computerized Tomography (CT) or Thoracic Ultrasound (TUS) provide images
deemed consistent with acute lung consolidation and suitable to confirm the diagnosis of
community acquired pneumonia (CAP). Patients which may be affected by CAP are many , but
diagnosis is not straightforward because we are managing "a disease characterized by educated
guesswork" . Comprehensive imaging workup may be not regularly affordable in busy emergency
rooms. Point-of-care TUS allows reliable diagnosis of lung consolidation and of pleural
effusion. Regretfully, adequate TUS expertise is more warranted than actually available in
most medical departments. Even not specifically investigated, a delay or even an impairment
of appropriate TUS or CXR evaluation for several patients may occur due to time- or
resource-limiting factors.
Clinical clues of lung consolidation are many. Key symptoms are cough, fever, chest pain and
dyspnea with tachypnea, while the major physical signs are chest crackles and dullness.
Surrogate biomarkers more easily obtainable in emergency facilities are C-reactive-protein
(CRP), peripheral non-invasive pulse-oxymetry and neutrophil-to-lymphocyte ratio (NLR) which
is an index of systemic inflammation associated also with pneumonia and subsequent outcome.
The aim of this preliminary study is to evaluate if any clue and which biomarker, including
NLR, assessed at Emergency Department (ED) triage, is predictive of the subsequent detection
of lung consolidation by TUS and/or by CXR.
The minimal groups' size, with and without TUS or CXR lung consolidation, was calculated
according to the difference of the averages of neutrophil-to-lymphocyte ratio (NLR) in the
reference the study of Yoon et al. Accepting alpha 0.01, for the probability of type 1 error,
and power 80% for probability of type 2 error, a minimum sample size of 19 participants in
each group (total 38) was required. Student's t-tests assessed the differences of CRP, WBC -
white blood cells count - (TLC), neutrophil count (TNC) and NLR, between the groups with TUS
and, separately, with CXR lung consolidation.Thereafter, by ROC (receiver operating curve)
analysis, a cutoff of NLR, total leucocytes count (TLC), total Neutrophil count (TNC) and of
CRP was calculated vs. the optimal reliability for the detection of TUS consolidation;
sensitivity, specificity and accuracy (The proportion of all tests that are correct), and
relative Odds Ratio (OR) and confidence intervals (CI) of the individual symptoms, and ORs of
so defined laboratory assay cut-offs were calculated separately vs. TUS and CXR
consolidation.
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