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

Ultrasound Therapy; Complications Clinical Trial

— AmbuLUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04602234
• Other study ID #: 2019-A00205)52
• Status: Completed
• Phase: N/A
• Start date: December 30, 2019
• Est. completion date: March 18, 2020

Study information

• Verified date: October 2020
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: March 18, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months and older

Eligibility

Inclusion Criteria:

• Age > 3 months

• Dyspnea or cough complaint

Exclusion Criteria:

• Age < 3 months

• Rejection to participate to the study

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Lower Resp Tract Infection
• Respiratory Tract Infections
• Ultrasound Therapy; Complications

Intervention

Diagnostic Test:
• Lung ultrasonography
Investigators performed lung ultrasonography on patients

Locations

Country	Name	City	State
France	University Hospital, Caen	Caen	Calvados

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

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