Lung Ultrasound for Community-acquired Pneumonia Diagnosis in Emergency Medicine

Community Acquired Pneumonia Clinical Trial

— ECHOPAC  

Official title:

Lung Ultrasound for Community-acquired Pneumonia Diagnosis in Emergency Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411824
• Other study ID #: RC16_0439
• Status: Completed
• Start date: November 8, 2016
• Est. completion date: February 8, 2019

Study information

• Verified date: March 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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 )

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 8, 2019
• Est. primary completion date: February 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria :

• clinical suspicion of PAC

Exclusion Criteria :

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

Related Conditions & MeSH terms

• Community Acquired Pneumonia
• Emergencies
• Pneumonia

Intervention

Other:
• no intervention
Non applicable

Locations

Country	Name	City	State
France	La Roche Sur Yon Hospital	La Roche-sur-Yon
France	Nantes University Hospital	Nantes
France	Poitiers University Hospital	Poitiers
France	Saint-Nazaire Hospital	Saint-Nazaire

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Frequency of Antibiotic prescription modification after LUS	95% confidence interval of antibiotic prescription intention frequency	Day 0