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Completed

NCT Number: NCT03411824

Lung Ultrasound for Community-acquired Pneumonia Diagnosis in Emergency Medicine

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 .

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Key information

Conditions

Community Acquired Pneumonia Community-Acquired Infections Community-Acquired Pneumonia Disease Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

La Roche Sur Yon Hospital, La Roche-sur-Yon, France

Loading trial locations.

About this study

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 )

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinical suspicion of PAC

Exclusion criteria

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

Treatment and study plan

No intervention

Other

Non applicable

Primary outcomes

  1. Frequency of PAC classification modification (definite, probable, possible, excluded) after LUS realization

    Time frame: Day 0

    95% confidence interval of CAP classification modification frequency before and after LUS realization

Secondary outcomes

  1. Concordancy of CAP classification diagnosis concordancy ( after LUS) compared to adjudication committee

    Time frame: 28 days after enrollment

    CAP classification (definite, probable, possible, excluded) and kappa coefficient.

  2. Frequency of Antibiotic prescription modification after LUS

    Time frame: Day 0

    95% confidence interval of antibiotic prescription intention frequency

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: ECHOPAC

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 26, 2018
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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