Focused Lung Ultrasound: A Prospective Cohort Study in General Practice

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections; Pneumonia; Ultrasonography; General Practice
• Intervention / Treatment: Other: FLUS

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9220
    • Center for General Practice at Aalborg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

GPs: Eligible GPs who are interested in participating will be identified through our GP network, the Facebook page for Center for General Practice at Aalborg University, the Facebook group Ultralyd i almen praksis I Danmark [Ultrasound in general practice in Denmark] and via our collaboration with the Danish Society for Ultrasound in General Practice (DAUS). Ten GPs will be selected based on demographics, experience with PoCUS, experience with FLUS, organisational aspects of the clinic and number of years as a general practitioner.

Patients: Eligible patients will be identified when they present to general practice. Written and oral information about the study will be provided by the GP to all potential participants and if they consent to participate, they will be included.

Description

Inclusion Criteria (GPs):

GPs who use PoCUS (Point-of-Care Ultrasound) at least once a week in general practice or out-of-hour services.

Inclusion Criteria (Patients):

Patients aged ≥ 18 years with acute cough (< 28 days) and at least one other symptom of an acute LRTI and where the GP suspects CAP.

Exclusion Criteria (Patients):

• Previous antibiotic prescription for the current episode of acute LRTI.
• Patients not listed with the GP (no medical record available).
• The patient is not capable of understanding and signing informed consent.
• The patient does not wish to participate in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Usual care + 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.

Other: FLUS; The participating GPs use ultrasonography on a weekly basis and will use the ultrasonography device already available to them; however, the ultrasound machine system and type of transducer will be reported. The GPs will use a 14-zone FLUS scanning protocol that has previously been validated in a general practice setting. Each of the scanning zones on the patient's left side can be denoted from 1L to 7L and from 1R to 7R on the right side. Each scanning zone should be assessed using FLUS. The transducer is placed in the middle of a scanning zone making a cross sectional image of an intercostal space and the underlying pleura blades. The patients will be examined in an upright position. The GPs will be trained in the 14-zone scanning protocol during a FLUS training program prior to recruitment of patients. FLUS pathological findings are predefined, and the variables will be dichotomized into present or not present for each scanning zone.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of FLUS findings	Distribution of FLUS findings in each of the 14 scanning zones.	2022
FLUS image quality	Proportion of FLUS examinations with acceptable image quality assessed by expert reviewers.	2022
Agreement on FLUS findings	Level of agreement between GPs and expert reviewers on FLUS findings.	2022
Unexpected events	Any unexpected events during the FLUS examination.	2022
Clinical impact of FLUS	Clinical impact of FLUS on antibiotics prescription, working diagnosis, confidence in working diagnosis, plans for treatment and visitation.	2022
FLUS feasibility	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.	2022
Characteristics of patients	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.	2022
Complications and hospitalisation	Number of reported complications and hospitalisations within 28 days of follow-up. Complications included: Empyema, lung abscess, pleural effusion or sepsis.	2022
GP follow-up initiatives	Any GP follow-up initiatives within 28 days of follow-up.	2022

Collaborators and Investigators

• Sponsor: Aalborg University
• Investigators: Principal Investigator: Julie J Strøm, MD, Aalborg University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): May 5, 2022
• Study Completion (Actual): June 5, 2022

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 194-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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