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OpenTrials
Completed

NCT Number: NCT04602234

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

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.

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Key information

Conditions

Lower Resp Tract Infection Ultrasound Therapy; Complications

Age range

3 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Caen

Caen, Calvados, 14000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 3 months
  • Dyspnea or cough complaint

Exclusion criteria

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

Treatment and study plan

Lung ultrasonography

Diagnostic Test

Investigators performed lung ultrasonography on patients

Primary outcomes

  1. Diagnosis modification

    Time frame: 3 months

    Diagnosis modification after lung ultrasonography

Secondary outcomes

  1. Therapeutic modification

    Time frame: 3 months

    Therapeutic modification after lung ultrasonography

  2. Imagery prescription

    Time frame: 3 months

    Decision of imagery prescription after lung ultrasonography

  3. Decision of hospitalization

    Time frame: 3 months

    Decision of an hospitalization or not after lung ultrasonography

  4. Medical evolution

    Time frame: 3 months

    Medical evolution at 7 days (improvement, persistence, worsening and hospitalization)

  5. Imagery result

    Time frame: 3 months

    Result of imagery initially prescribed by general practitioners (Chest CT-Scan or X-Ray)

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: AmbuLUS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 26, 2020
Registry last updated
Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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