Clinical trial NCT04711031: Focused Lung Ultrasound: A Prospective Cohort Study in General Practice
Official title: Focused Lung Ultrasound: A Prospective Cohort Study in General Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasonography
Respiratory Tract Infections
Pneumonia
General Practice
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: FLUS findings
timeFrame: 2022
Secondary outcomes:
measure: Distribution of FLUS findings
timeFrame: 2022
measure: FLUS image quality
timeFrame: 2022
measure: Agreement on FLUS findings
timeFrame: 2022
measure: Unexpected events
timeFrame: 2022
measure: Clinical impact of FLUS
timeFrame: 2022
measure: FLUS feasibility
timeFrame: 2022
measure: Characteristics of patients
timeFrame: 2022
measure: Complications and hospitalisation
timeFrame: 2022
measure: GP follow-up initiatives
timeFrame: 2022
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Center for General Practice at Aalborg University
Study officials:
affiliation: Aalborg University
name: Julie J Strøm, MD
role: PRINCIPAL_INVESTIGATOR
References: