Community-Acquired Pneumonia Diagnosis Using Lung Ultrasound in Emergency Room Adults

Not Applicable

• Conditions: Community-acquired Pneumonia
• Interventions: Diagnostic Test: Lung Ultrasound (LUS); Diagnostic Test: Chest radiography (CR)

• Registration Number: NCT04210102
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

Community-Acquired Pneumonia (CAP) is a major problem in Emergency Department (ED). Diagnosis relies on combination of clinical symptoms and results of chest radiography (CR). Patients' management (treatment, support) depends on delay and quality of the diagnosis. However, signs and symptoms are highly aspecific and interpretation of CR is subject to frequent discrepancies. Then diagnosis of CAP may be uncertain; therefore, overdiagnosis is frequent and leads to over-use of antimicrobial therapy; missing diagnosis is also deleterious and delays adequate treatment including antibiotics. CT scan completes CR and helps clinician making properly diagnosis of CAP; obtaining CT in a 4-hour time-lapse allows better diagnosis and management as accurate as an independent expert adjudication committee does. However availability of CT as well as radiation interrogates on the benefit that Lung Ultrasounds (LUS) may have in diagnosis strategy of suspected CAP. LUS is a noninvasive easy-to-use device whose practice is widely endorsed worldwide by emergency medicine associations and societies. Additionally, previous studies advocate for the use of LUS for diagnosis of CAP in the ED. Therefore the Promotor developed a study to compare LUS and CR as a primary imaging for diagnosis of CAP at the ED.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-24
• Last Update Submitted: 2020-02-07
• Last Update Posted: 2020-02-10
• Study Start: 2020-02-15
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

• Adult patients (18+)
• Suspected CAP by attending emergency physician
• And new onset of systemic infection (at least one among sweat, chills, aches and pain, temperature ≥38°C or <36°C)
• And symptoms of an acute lower respiratory tract infection (at least one among cough, sputum production, dyspnea, chest pain, altered breathing sounds at auscultation
• No previous imaging for the current medical problem
• Inform consent (signed)
• Affiliation to insurance (France, Monaco)

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Exclusion Criteria

• Age below 18-year of age
• Patients in palliative care
• Pregnant women
• anticipated barriers to completing follow-up data collection,
• patients classified three or higher according to the CRB65 score,
• patients requiring intensive care for any purpose because of specific management of critically ill
• refusal to participate to the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CR + LUS	Lung Ultrasound (LUS)	Patient will be performed first the Chest radiography then the Lung ultrasound.
CR + LUS	Chest radiography (CR)	Patient will be performed first the Chest radiography then the Lung ultrasound.
LUS + CR	Lung Ultrasound (LUS)	Patient will be performed first the Lung ultrasound then the Chest radiography
LUS + CR	Chest radiography (CR)	Patient will be performed first the Lung ultrasound then the Chest radiography

Primary Outcome Measures

Name	Time	Method
The sensitivity of lung ultrasound (LUS) and chest X-ray (CR) to detect community-acquired pneumonia (CAP) will be mesured and compared in patients visiting the emergency department for suspected CAP	Within the day of inclusion

Secondary Outcome Measures

Name	Time	Method
specificity, positive predictive value and negative predictive value : indicators of diagnosis performance, will be measured and compared as a primary imaging for diagnosis of CAP	Within the day of inclusion
Specificity, positive predictive value, negative predictive value will be measured and compared in each sequence of imaging (CR + LUS and LUS + CR) for CAP detection	Within the day of inclusion
medical decisions for diagnosis of CAP after each step LUS then CR or CR then LUS and after low dose CT6scan (CT) will be compared to the medical decisions of the adjudication committee	Up to 6 months
The concordance of interpretation (for CR and CT) between attending radiologist and expert radiologist of the adjudication committee (gold standard) wil be studied.	Up to 6 months