Focused Lung Ultrasound: A Prospective Cohort Study in General Practice

Study Overview
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Brief Summary
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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.

Official Title
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Focused Lung Ultrasound: A Prospective Cohort Study in General Practice

Conditions
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Ultrasonography, Respiratory Tract Infections, Pneumonia, General Practice

Intervention / Treatment
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* Other: FLUS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Usual care + FLUS<br>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<br>* 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.<br>|

What is the study measuring?
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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 |