Diagnostic of Lower Respiratory Tract Infection by Lung U... | NCT04602234

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

NCT04602234

Sponsor

University Hospital, Caen

Status

Completed

Last Update Posted

Oct 26, 2020Actual

Enrollment

151Actual

Phase

Not Applicable

Conditions

Lower Resp Tract Infection
Ultrasound Therapy; Complications

Interventions

Lung ultrasonography

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 30, 2019Actual

Primary Completion Date

Mar 11, 2020Actual

Completion Date

Mar 18, 2020Actual

First Submitted Date

Oct 20, 2020

First Submission Date that Met QC Criteria

Oct 20, 2020

First Posted Date

Oct 26, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2020

Last Update Posted Date

Oct 26, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

151Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LUS group	Experimental		Diagnostic Test: Lung ultrasonography
No LUS group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lung ultrasonography	Diagnostic Test	Investigators performed lung ultrasonography on patients	LUS group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Therapeutic modification	Therapeutic modification after lung ultrasonography	3 months
Imagery prescription	Decision of imagery prescription after lung ultrasonography

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 3 months
Dyspnea or cough complaint

Exclusion Criteria:

Age < 3 months
Rejection to participate to the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital, Caen		Caen	Calvados	14000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38767949	Derived	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.