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Completed

NCT Number: NCT03212248

CRP and 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.

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Key information

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

MCAU

Catania, Please Select An Option Below, 95131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

presence of history and symptoms, signs at physical examination and early laboratory clues of CAP According to the preliminary triage, in all patients, as a routine assessment, breath frequency, blood pressure and heart rate, pulse oxymetry, serum and blood analysis including creatinine and urea, CRP, blood cell counts and hemoglobin assay, were performed, also for CURB65 staging. ECG was preliminary done in all patients with chest pain, dyspnea and/or fever.

Exclusion criteria

-

Treatment and study plan

Thoracic Ultrasound (TUS)

Diagnostic Test

Primary outcomes

  1. Odds of detecting lung consolidation by TUS according to symptoms or biomarkers' cutoffs

    Time frame: ten minutes

    ultrasound

Secondary outcomes

  1. Odds of detecting lung consolidation by Chest X Rays (CXR) according to symptoms or biomarkers' cutoffs

    Time frame: ten minutes

    radiology

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

Other

Collaborators

  • Ospedale Civile di Ragusa, Italy

Registry information

Official study title

CRP (C-Reactive-Protein) and Pneumonia Biomarkers Stratification for Selectively Addressing Priorities in Thoracic Emergency Ultrasound in Pneumonia

Acronym: TUS-STRAT

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jul 11, 2017
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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