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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
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

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

3 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 20, 2020
Last Updated
October 20, 2020
Sponsor
University Hospital, Caen
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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

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Diagnostic of Lower Respiratory Tract Infection by Lung Ultrasonography in General Practice

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