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Completed

NCT Number: NCT04711031

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.

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Key information

Conditions

Ultrasonography General Practice Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for General Practice at Aalborg University

Aalborg, 9220, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. FLUS findings

    Time frame: 2022

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

Secondary outcomes

  1. Distribution of FLUS findings

    Time frame: 2022

    Distribution of FLUS findings in each of the 14 scanning zones.

  2. FLUS image quality

    Time frame: 2022

    Proportion of FLUS examinations with acceptable image quality assessed by expert reviewers.

  3. Agreement on FLUS findings

    Time frame: 2022

    Level of agreement between GPs and expert reviewers on FLUS findings.

  4. Unexpected events

    Time frame: 2022

    Any unexpected events during the FLUS examination.

  5. Clinical impact of FLUS

    Time frame: 2022

    Clinical impact of FLUS on antibiotics prescription, working diagnosis, confidence in working diagnosis, plans for treatment and visitation.

  6. FLUS feasibility

    Time frame: 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.

  7. Characteristics of patients

    Time frame: 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.

  8. Complications and hospitalisation

    Time frame: 2022

    Number of reported complications and hospitalisations within 28 days of follow-up. Complications included: Empyema, lung abscess, pleural effusion or sepsis.

  9. GP follow-up initiatives

    Time frame: 2022

    Any GP follow-up initiatives within 28 days of follow-up.

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 15, 2021
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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