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

Not Applicable

Completed

• Conditions: Lower Resp Tract Infection; Ultrasound Therapy; Complications
• Interventions: Diagnostic Test: Lung ultrasonography

• Registration Number: NCT04602234
• Lead Sponsor: University Hospital, Caen

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.

Study Timeline

• Study Start: 2019-12-30
• Primary Completion: 2020-03-11
• Study Completion: 2020-03-18
• Status Verified: 2020-10
• Study First Submitted: 2020-10-20
• Study First Submitted QC: 2020-10-20
• Last Update Submitted: 2020-10-20
• Study First Posted: 2020-10-26
• Last Update Posted: 2020-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• Age > 3 months
• Dyspnea or cough complaint

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LUS group	Lung ultrasonography	-

Primary Outcome Measures

Name	Time	Method
Diagnosis modification	3 months	Diagnosis modification after lung ultrasonography

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital, Caen; 🇫🇷 Caen, Calvados, France