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

October 20, 2020 updated by: University Hospital, Caen

Diagnosis of Lower Respiratory Tract Infection by Lung Ultrasonography in General Practice : a Prospective, Interventional and Multicentric Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Calvados
      • Caen, Calvados, France, 14000
        • University Hospital, Caen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 3 months
  • Dyspnea or cough complaint

Exclusion Criteria:

  • Age < 3 months
  • Rejection to participate to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LUS group
Diagnostic test: Lung ultrasonography
Investigators performed lung ultrasonography on patients
NO_INTERVENTION: No LUS group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis modification
Time Frame: 3 months
Diagnosis modification after lung ultrasonography
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapeutic modification
Time Frame: 3 months
Therapeutic modification after lung ultrasonography
3 months
Imagery prescription
Time Frame: 3 months
Decision of imagery prescription after lung ultrasonography
3 months
Decision of hospitalization
Time Frame: 3 months
Decision of an hospitalization or not after lung ultrasonography
3 months
Medical evolution
Time Frame: 3 months
Medical evolution at 7 days (improvement, persistence, worsening and hospitalization)
3 months
Imagery result
Time Frame: 3 months
Result of imagery initially prescribed by general practitioners (Chest CT-Scan or X-Ray)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 30, 2019

Primary Completion (ACTUAL)

March 11, 2020

Study Completion (ACTUAL)

March 18, 2020

Study Registration Dates

First Submitted

October 20, 2020

First Submitted That Met QC Criteria

October 20, 2020

First Posted (ACTUAL)

October 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A00205)52

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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