Diagnostic of Lower Respiratory Tract Infection by Lung Ultrasonography in General Practice (AmbuLUS)
Primary Purpose
Lower Resp Tract Infection, Ultrasound Therapy; Complications
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Lung ultrasonography
Sponsored by
About this trial
This is an interventional diagnostic trial for Lower Resp Tract Infection focused on measuring Lung ultrasonography, Lower Respiratory Tract Infection, General Practice
Eligibility Criteria
Inclusion Criteria:
- Age > 3 months
- Dyspnea or cough complaint
Exclusion Criteria:
- Age < 3 months
- Rejection to participate to the study
Sites / Locations
- University Hospital, Caen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
LUS group
No LUS group
Arm Description
Outcomes
Primary Outcome Measures
Diagnosis modification
Diagnosis modification after lung ultrasonography
Secondary Outcome Measures
Therapeutic modification
Therapeutic modification after lung ultrasonography
Imagery prescription
Decision of imagery prescription after lung ultrasonography
Decision of hospitalization
Decision of an hospitalization or not after lung ultrasonography
Medical evolution
Medical evolution at 7 days (improvement, persistence, worsening and hospitalization)
Imagery result
Result of imagery initially prescribed by general practitioners (Chest CT-Scan or X-Ray)
Full Information
NCT ID
NCT04602234
First Posted
October 20, 2020
Last Updated
October 20, 2020
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT04602234
Brief Title
Diagnostic of Lower Respiratory Tract Infection by Lung Ultrasonography in General Practice
Acronym
AmbuLUS
Official Title
Diagnosis of Lower Respiratory Tract Infection by Lung Ultrasonography in General Practice : a Prospective, Interventional and Multicentric Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 30, 2019 (Actual)
Primary Completion Date
March 11, 2020 (Actual)
Study Completion Date
March 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Lower Respiratory Tract Infection (LRTI) is a frequent motive of consultation in General Practice. Cost, irradiation and availability of traditional imagery make it difficult to perform in every patient with suspected LRTI.
The objective is to evaluate the performance of LUS realized by family physicians into the usual LRTI diagnostic pathway.
This study is a prospective, interventional, multi-centric and open study conducted in 3 different centers by 15 General Practitioners (GP) in France. Patient complaining of dyspnea or cough were recruited from December 2019 to March 2020. GP received a training course by LUS expert before the study.
The primary outcome measure was diagnosis modification after LUS. Secondary measures were therapeutic modification after LUS, decision of imagery prescription after LUS, decision of hospitalization or not after LUS, medical evolution and result of imagery initially prescribed by GP.
Detailed Description
After an initial medical report, GP's concluded to an initial diagnosis and make initial prescription and finally decided or not to perform a standardized eight-points LUS. GP were free to perform or not LUS. If GP decided to perform LUS, GP were allowed to change their diagnosis and prescriptions (LUS group). However, therapeutic changes after LUS could not "downgrade" patient care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Resp Tract Infection, Ultrasound Therapy; Complications
Keywords
Lung ultrasonography, Lower Respiratory Tract Infection, General Practice
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Among the 151 patients included, 111 LUS were performed (LUS group)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LUS group
Arm Type
Experimental
Arm Title
No LUS group
Arm Type
No Intervention
Intervention Type
Diagnostic Test
Intervention Name(s)
Lung ultrasonography
Intervention Description
Investigators performed lung ultrasonography on patients
Primary Outcome Measure Information:
Title
Diagnosis modification
Description
Diagnosis modification after lung ultrasonography
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Therapeutic modification
Description
Therapeutic modification after lung ultrasonography
Time Frame
3 months
Title
Imagery prescription
Description
Decision of imagery prescription after lung ultrasonography
Time Frame
3 months
Title
Decision of hospitalization
Description
Decision of an hospitalization or not after lung ultrasonography
Time Frame
3 months
Title
Medical evolution
Description
Medical evolution at 7 days (improvement, persistence, worsening and hospitalization)
Time Frame
3 months
Title
Imagery result
Description
Result of imagery initially prescribed by general practitioners (Chest CT-Scan or X-Ray)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 3 months
Dyspnea or cough complaint
Exclusion Criteria:
Age < 3 months
Rejection to participate to the study
Facility Information:
Facility Name
University Hospital, Caen
City
Caen
State/Province
Calvados
ZIP/Postal Code
14000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Diagnostic of Lower Respiratory Tract Infection by Lung Ultrasonography in General Practice
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