CRP and Thoracic Emergency Ultrasound in Pneumonia

NCT03212248 | Completed

• 1 other identifier: TUS-STRAT
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Difference, Individual; Community-acquired Pneumonia; Ultrasound

Outcome Measures

Primary Outcomes (1)

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

  ultrasound

  ten minutes

Secondary Outcomes (1)

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

  ten minutes

Interventions

Thoracic Ultrasound (TUS) DIAGNOSTIC_TEST

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Criteria of exclusion: severe respiratory failure - pulse oxymetry ≥92%, myocardial infarction, acute pulmonary edema or severe heart failure, excluded on clinical basis, severe COPD excluded by patient's history and by subsequent CXR, CURB65 ≥3.

You may qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele: lead
• Ospedale Civile di Ragusa, Italy: collaborator

Study Sites (1)

MCAU

Catania, Please Select An Option Below, 95131, Italy

Location

Related Publications (7)

• Interrigi MC, Trovato FM, Catalano D, Trovato GM. Emergency thoracic ultrasound and clinical risk management. Ther Clin Risk Manag. 2017 Feb 9;13:151-160. doi: 10.2147/TCRM.S126770. eCollection 2017.

  PMID: 28223817 BACKGROUND

• Sperandeo M, Rea G, Grimaldi MA, Trovato F, Dimitri LM, Carnevale V. Contrast-enhanced ultrasound does not discriminate between community acquired pneumonia and lung cancer. Thorax. 2017 Feb;72(2):178-180. doi: 10.1136/thoraxjnl-2016-208913. Epub 2016 Oct 14.

  PMID: 27742872 BACKGROUND

• Trovato FM, Catalano D, Trovato GM. Thoracic ultrasound: An adjunctive and valuable imaging tool in emergency, resource-limited settings and for a sustainable monitoring of patients. World J Radiol. 2016 Sep 28;8(9):775-784. doi: 10.4329/wjr.v8.i9.775.

  PMID: 27721940 BACKGROUND

• Trovato FM, Catalano D. Diagnosis of Pneumonia by Lung Ultrasound in Children and Limited Resources Subsets: A Valuable Medical Breakthrough. Chest. 2016 Jul;150(1):258-60. doi: 10.1016/j.chest.2016.04.032. No abstract available.

  PMID: 27396790 BACKGROUND

• Waterer GW. The Diagnosis of Community-acquired Pneumonia. Do We Need to Take a Big Step Backward? Am J Respir Crit Care Med. 2015 Oct 15;192(8):912-3. doi: 10.1164/rccm.201507-1460ED. No abstract available.

  PMID: 26469839 BACKGROUND

• Cataudella E, Giraffa CM, Di Marca S, Pulvirenti A, Alaimo S, Pisano M, Terranova V, Corriere T, Ronsisvalle ML, Di Quattro R, Stancanelli B, Giordano M, Vancheri C, Malatino L. Neutrophil-To-Lymphocyte Ratio: An Emerging Marker Predicting Prognosis in Elderly Adults with Community-Acquired Pneumonia. J Am Geriatr Soc. 2017 Aug;65(8):1796-1801. doi: 10.1111/jgs.14894. Epub 2017 Apr 13.

  PMID: 28407209 BACKGROUND

• Yoon NB, Son C, Um SJ. Role of the neutrophil-lymphocyte count ratio in the differential diagnosis between pulmonary tuberculosis and bacterial community-acquired pneumonia. Ann Lab Med. 2013 Mar;33(2):105-10. doi: 10.3343/alm.2013.33.2.105. Epub 2013 Feb 21.

  PMID: 23482854 BACKGROUND

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• GUGLIELMO TROVATO, MD

  medint

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine - Research Project Planning Unit

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 11, 2017
• Study Start: January 2, 2016
• Primary Completion: April 30, 2016
• Study Completion: June 30, 2017
• Last Updated: July 11, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)