NCT04602234

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
Last Updated

October 26, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

October 20, 2020

Last Update Submit

October 20, 2020

Conditions

Keywords

Lung ultrasonographyLower Respiratory Tract InfectionGeneral Practice

Outcome Measures

Primary Outcomes (1)

  • Diagnosis modification

    Diagnosis modification after lung ultrasonography

    3 months

Secondary Outcomes (5)

  • Therapeutic modification

    3 months

  • Imagery prescription

    3 months

  • Decision of hospitalization

    3 months

  • Medical evolution

    3 months

  • Imagery result

    3 months

Study Arms (2)

LUS group

EXPERIMENTAL
Diagnostic Test: Lung ultrasonography

No LUS group

NO INTERVENTION

Interventions

Lung ultrasonographyDIAGNOSTIC_TEST

Investigators performed lung ultrasonography on patients

LUS group

Eligibility Criteria

Age3 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 3 months
  • Dyspnea or cough complaint

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Caen

Caen, Calvados, 14000, France

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Among the 151 patients included, 111 LUS were performed (LUS group)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2020

First Posted

October 26, 2020

Study Start

December 30, 2019

Primary Completion

March 11, 2020

Study Completion

March 18, 2020

Last Updated

October 26, 2020

Record last verified: 2020-10

Locations