Focused Lung Ultrasound: A Prospective Cohort Study in General Practice

NCT04711031 | Completed

• 1 other identifier: 194-1
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasonography; Respiratory Tract Infections; Pneumonia; General Practice

Outcome Measures

Primary Outcomes (1)

• FLUS findings

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

  2022

Secondary Outcomes (9)

• Distribution of FLUS findings

  2022

• FLUS image quality

  2022

• Agreement on FLUS findings

  2022

• Unexpected events

  2022

• Clinical impact of FLUS

  2022

Study Arms (1)

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

Interventions

FLUS OTHER

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.

Usual care + FLUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Center for General Practice at Aalborg University

Aalborg, 9220, Denmark

Location

Related Publications (1)

• Strom JJ, Andersen CA, Jensen MB, Thomsen JL, Laursen CB, Skaarup SH, Schultz HHL, Hansen MP. Evaluating general practitioners' focused lung ultrasound competence and findings in patients with suspected community-acquired pneumonia in general practice. Scand J Prim Health Care. 2025 Jun;43(2):359-369. doi: 10.1080/02813432.2024.2447083. Epub 2024 Dec 30.

  PMID: 39736112 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections; Pneumonia

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Lung Diseases

Study Officials

• Julie J Strøm, MD

  Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD Student

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: March 1, 2021
• Primary Completion: May 5, 2022
• Study Completion: June 5, 2022
• Last Updated: December 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

DK (1)