Clinical trial NCT03411824: Lung Ultrasound for Community-acquired Pneumonia Diagnosis in Emergency Medicine
Official title: Lung Ultrasound for Community-acquired Pneumonia Diagnosis in Emergency Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community Acquired Pneumonia
Keywords: diagnosis
Point-of-Care-Ultrasound
lung ultrasound
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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 )

Eligibility criteria: Inclusion Criteria :

- clinical suspicion of PAC

Exclusion Criteria :

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

Primary outcomes:
measure: Frequency of PAC classification modification (definite, probable, possible, excluded) after LUS realization
timeFrame: Day 0
Secondary outcomes:
measure: Concordancy of CAP classification diagnosis concordancy ( after LUS) compared to adjudication committee
timeFrame: 28 days after enrollment
measure: Frequency of Antibiotic prescription modification after LUS
timeFrame: Day 0
Other outcomes:
Locations:
city: La Roche-sur-Yon
country: France
facility: La Roche Sur Yon Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Saint-Nazaire
country: France
facility: Saint-Nazaire Hospital
Study officials:
affiliation: Nantes University Hospital
name: Philippe Le Conte, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.