NCT04644510

Brief Summary

A major barrier to ultrasonography in general practice (GP) is the time restriction of their medical consultation. We aimed to evaluate the feasibility of lung ultrasonography (LUS) realized by general practitioners (GP's) into their medical consultation. A prospective, observational, multi-centric and open study conducted in 3 different centers by 15 GP in France. Patient receiving LUS were recruited from December 2019 to January 2020. GP's were all novices and received a training course by LUS expert before the study. Eight-points LUS exam was recorded, timed, and interpreted by GP's. Among the 111 LUS performed, 110 LUS were interpreted. Time duration was 4 (3-5) min with 13% of LUS superior to 5 minutes. There was no significant difference in time duration after stratification by age. Patients were mainly satisfied after receiving LUS, and 80% of patients had a better understanding about their disease due to US realization. In this first prospective, and multicenter study, involving patients consulting in General Practice, we found that LUS seems to be feasible by GP's in a medical consultation. We showed that LUS can be performed fast enough for a GP consultation, and easy to learn. These findings will need to be valided in a randomized and controlled study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

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 17, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
Last Updated

November 25, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

November 20, 2020

Last Update Submit

November 20, 2020

Conditions

Keywords

UltrasonographyGeneral PracticeFeasabilityLung ultrasonography

Outcome Measures

Primary Outcomes (1)

  • Duration of Lung Ultrasonography

    2 months

Secondary Outcomes (4)

  • Time limit exceeded lung ultrasonography

    2 months

  • Interpretation of lung ultrasonography images

    2 months

  • Stratification by age

    2 months

  • Survey results

    2 months

Study Arms (1)

Lung ultrasonography group

Patient which benefited from a Lung ultrasonography during the medical consultation

Device: Lung ultrasonography

Interventions

Standardized eight-point Lung ultrasonography

Lung ultrasonography group

Eligibility Criteria

Age3 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients consulting their family physician

You may qualify if:

  • Age \> 3 months; lung ultrasonography performed by GP

You may not qualify if:

  • Age \< 3 months or 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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2020

First Posted

November 25, 2020

Study Start

December 17, 2019

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

November 25, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations