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

NCT ID: NCT04602234

Last Updated: 2020-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-30

Study Completion Date

2020-03-18

Brief Summary

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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

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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.

Conditions

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Lower Resp Tract Infection Ultrasound Therapy; Complications

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Among the 151 patients included, 111 LUS were performed (LUS group)
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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LUS group

Group Type EXPERIMENTAL

Lung ultrasonography

Intervention Type DIAGNOSTIC_TEST

Investigators performed lung ultrasonography on patients

No LUS group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lung ultrasonography

Investigators performed lung ultrasonography on patients

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age \> 3 months
* Dyspnea or cough complaint

Exclusion Criteria

* Age \< 3 months
* Rejection to participate to the study
Minimum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital, Caen

Caen, Calvados, France

Site Status

Countries

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France

References

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Amiot F, Delomas T, Laborne FX, Ecolivet T, Macrez R, Benhamed A. Implementation of lung ultrasonography by general practitioners for lower respiratory tract infections: a feasibility study. Scand J Prim Health Care. 2024 Sep;42(3):463-470. doi: 10.1080/02813432.2024.2343678. Epub 2024 May 20.

Reference Type DERIVED
PMID: 38767949 (View on PubMed)

Other Identifiers

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2019-A00205)52

Identifier Type: -

Identifier Source: org_study_id