Feasability of Lung Ultrasonography in General Practice

Education Clinical Trial

— AmBulUs  

Official title:

Feasability of Lung Ultrasonography in General Practice: A Multicentic, Observational and Descriptive Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04644510
• Other study ID #: 19-023
• Secondary ID: 2019-A00205-52
• Status: Completed
• Start date: December 17, 2019
• Est. completion date: January 31, 2020

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months and older

Eligibility

Inclusion Criteria:

• Age > 3 months; lung ultrasonography performed by GP

Exclusion Criteria:

• Age < 3 months or rejection to participate to the study

Related Conditions & MeSH terms

• Education
• General Practice
• Ultrasonography

Intervention

Device:
• Lung ultrasonography
Standardized eight-point Lung ultrasonography

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	Duration of Lung Ultrasonography		2 months
Secondary	Time limit exceeded lung ultrasonography	Superior to 5 minutes	2 months
Secondary	Interpretation of lung ultrasonography images		2 months
Secondary	Stratification by age	3 groups : < 18 years-old, 18-65 years-old, > 65 years-old	2 months
Secondary	Survey results		2 months