Ignite Creation Date:
2024-05-06 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03411824
Status:
COMPLETED
Last Update Posted:
2021-03-19
First Post:
2017-11-30
Brief Title:
Lung Ultrasound for Community-acquired Pneumonia Diagnosis in Emergency Medicine
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Lung Ultrasound for Community-acquired Pneumonia Diagnosis in Emergency Medicine
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECHOPAC
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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None