Feasability of Lung Ultrasonography in General Practice (AmBulUs)

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

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.

Study Overview

• Status: Completed
• Conditions: Ultrasonography; Education; General Practice
• Intervention / Treatment: Device: Lung ultrasonography

• Study Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• France
  • Calvados
    • Caen, Calvados, France, 14000
      • University Hospital, Caen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients consulting their family physician

Description

Inclusion Criteria:

• Age > 3 months; lung ultrasonography performed by GP

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lung ultrasonography group; Patient which benefited from a Lung ultrasonography during the medical consultation	Device: Lung ultrasonography; Standardized eight-point Lung ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of Lung Ultrasonography	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time limit exceeded lung ultrasonography	Superior to 5 minutes	2 months
Interpretation of lung ultrasonography images		2 months
Stratification by age	3 groups : < 18 years-old, 18-65 years-old, > 65 years-old	2 months
Survey results		2 months

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 17, 2019
• Primary Completion (ACTUAL): January 31, 2020
• Study Completion (ACTUAL): January 31, 2020

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (ACTUAL): November 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 25, 2020
• Last Update Submitted That Met QC Criteria: November 20, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: General Practice; Ultrasonography; Feasability; Lung ultrasonography
• Other Study ID Numbers: 19-023; 2019-A00205-52 (OTHER: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No