Lung Ultrasound for Community-acquired Pneumonia Diagnosis in Emergency Medicine

Completed

• Conditions: Community Acquired Pneumonia

• Registration Number: NCT03411824
• Lead Sponsor: Nantes University Hospital

Brief Summary

Community-acquired pneumonia (CAP) is frequently suspected in the Emergency Department (ED). However, usual diagnosis procedure based on clinical features and chest X-Ray has rather bad performances.

A recent study on CT performance in suspected CAP found that 58% of classifications were modified by CT when compared with usual procedure. However, extended CT usage in CAP diagnosis is associated with many limitations :

availability in a majority of ED, delay, cost and irradiation, in particular In young patients.

Lung Ultrasound (LUS) has good performances in CAP diagnosis even when compared with CT. It is a rapid, inexpensive, radiation-free tool available in a majority of ED. It is performed at the patient's bedside with immediate results. The learning curve allows Emergency Physicians (EP) to perform this exam after a relative brief training.

The Investigators aim to investigate LUS performances in clinically suspected CAP authentication , and assesses specific diagnostic contributions and impact on antibiotic prescriptions .

Detailed Description

120 patients will be enrolled on CAP suspicion. All explorations (radiography...) and biological exams (blood culture...) will be performed as usual to build physician primary diagnosis. Complementarily, an EP will be realized and final diagnosis will be made by physician. Finally, at Day28 expert adjudication committee will authentic diagnosis considering explorations and clinical issues. Frequency of discordant diagnosis between 1st and 2nd assessment and against expert will be measured Primary Purpose: diagnostic Study Phase: Not Applicable Intervention Model: NA Number of Arms: 1 Masking: open label, Masked Roles: NA Allocation: NA Study Endpoint Classification: efficacy Enrollment: 120 subjects (anticipated )

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-11-08
• Study First Submitted: 2017-11-30
• Study First Submitted QC: 2018-01-19
• Study First Posted: 2018-01-26
• Primary Completion: 2019-02-08
• Study Completion: 2019-02-08
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of PAC classification modification (definite, probable, possible, excluded) after LUS realization	Day 0	95% confidence interval of CAP classification modification frequency before and after LUS realization

Secondary Outcome Measures

Name	Time	Method
Concordancy of CAP classification diagnosis concordancy ( after LUS) compared to adjudication committee	28 days after enrollment	CAP classification (definite, probable, possible, excluded) and kappa coefficient.
Frequency of Antibiotic prescription modification after LUS	Day 0	95% confidence interval of antibiotic prescription intention frequency

Trial Locations

Locations (4)

Nantes University Hospital; 🇫🇷 Nantes, France

Saint-Nazaire Hospital; 🇫🇷 Saint-Nazaire, France

La Roche Sur Yon Hospital; 🇫🇷 La Roche-sur-Yon, France

Poitiers University Hospital; 🇫🇷 Poitiers, France