Focused Lung Ultrasound: A Prospective Cohort Study in General Practice

Completed

• Conditions: Ultrasonography; Respiratory Tract Infections; Pneumonia; General Practice
• Interventions: Other: FLUS

• Registration Number: NCT04711031
• Lead Sponsor: Aalborg University

Brief Summary

This is a prospective cohort study that describes focused lung ultrasound (FLUS) findings in patients presenting with symptoms of an acute lower respiratory tract infection (LRTI) in general practice in Denmark.

Ten general practitioners (GPs) will perform FLUS in addition to their usual care of adults presenting with symptoms of an acute LRTI where the GP suspects a community-acquired pneumonia (CAP). Eligible patients will consecutively be invited to participate during a two months' study period until each GP has included a total of ten patients. The GPs will register information about patients including age, gender, symptoms, clinical findings, results of any point-of-care test performed, if antibiotic treatment was prescribed and they will register information on FLUS performance and findings.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-15
• Study Start: 2021-03-01
• Primary Completion: 2022-05-05
• Study Completion: 2022-06-05
• Status Verified: 2023-08
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Usual care + FLUS	FLUS	At index consultation, patients will receive a FLUS examination in addition to the GP's usual care of adults presenting with symptoms of an acute LRTI.

Primary Outcome Measures

Name	Time	Method
FLUS findings	2022	Description of FLUS findings in patients with symptoms of acute LRTI in general practice where the GP suspects CAP.

Secondary Outcome Measures

Name	Time	Method
Agreement on FLUS findings	2022	Level of agreement between GPs and expert reviewers on FLUS findings.
Characteristics of patients	2022	Characteristics of patients including age, gender, symptoms, clinical findings, results of any point-of-care test performed, if antibiotic treatment was prescribed, referral to secondary care for other imaging, examination or treatment.
Distribution of FLUS findings	2022	Distribution of FLUS findings in each of the 14 scanning zones.
FLUS image quality	2022	Proportion of FLUS examinations with acceptable image quality assessed by expert reviewers.
Unexpected events	2022	Any unexpected events during the FLUS examination.
GP follow-up initiatives	2022	Any GP follow-up initiatives within 28 days of follow-up.
FLUS feasibility	2022	Number of patients where FLUS was not performed or only partially completed and the reasons for this. Number of technical breakdowns or ultrasound machine not available.
Clinical impact of FLUS	2022	Clinical impact of FLUS on antibiotics prescription, working diagnosis, confidence in working diagnosis, plans for treatment and visitation.
Complications and hospitalisation	2022	Number of reported complications and hospitalisations within 28 days of follow-up. Complications included: Empyema, lung abscess, pleural effusion or sepsis.

Trial Locations

Locations (1)

Center for General Practice at Aalborg University; 🇩🇰 Aalborg, Denmark