Lung Ultrasound for Community-acquired Pneumonia Diagnosis in Emergency Medicine (ECHOPAC)

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 .

Study Overview

• Status: Completed
• Conditions: Community Acquired Pneumonia
• Intervention / Treatment: Other: no intervention

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 )

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• France
  • La Roche-sur-Yon, France, 85925
    • La Roche sur Yon Hospital
  • Nantes, France, 44093
    • Nantes University Hospital
  • Poitiers, France, 86000
    • Poitiers University Hospital
  • Saint-Nazaire, France, 44606
    • Saint-Nazaire Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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 authentify diagnosis considering explorations and clinical issues. Frequency of discordant diagnosis between 1st and 2nd assessment and against expert will be measured

Description

Inclusion Criteria :

- clinical suspicion of PAC

Exclusion Criteria :

• documented end-of-life
• pregnancy
• seriously ill patients

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Philippe Le Conte, Pr, Nantes University Hospital

Publications and helpful links

General Publications

• Javaudin F, Marjanovic N, de Carvalho H, Gaborit B, Le Bastard Q, Boucher E, Haroche D, Montassier E, Le Conte P. Contribution of lung ultrasound in diagnosis of community-acquired pneumonia in the emergency department: a prospective multicentre study. BMJ Open. 2021 Sep 24;11(9):e046849. doi: 10.1136/bmjopen-2020-046849.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2016
• Primary Completion (Actual): February 8, 2019
• Study Completion (Actual): February 8, 2019

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: January 19, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: lung ultrasound; diagnosis; Point-of-Care-Ultrasound
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Emergencies; Pneumonia
• Other Study ID Numbers: RC16_0439

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No