Focused Lung Ultrasound: A Prospective Cohort Study in General Practice

Sponsor
Aalborg University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04711031
Collaborator
(none)
100
1
17
5.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: FLUS

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Focused Lung Ultrasound: A Prospective Cohort Study in General Practice
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. FLUS findings [2022]

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

Secondary Outcome Measures

  1. Distribution of FLUS findings [2022]

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

  2. FLUS image quality [2022]

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

  3. Agreement on FLUS findings [2022]

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

  4. Unexpected events [2022]

    Any unexpected events during the FLUS examination.

  5. Clinical impact of FLUS [2022]

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

  6. FLUS feasibility [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 [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 [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 [2022]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for General Practice at Aalborg University Aalborg Denmark 9220

Sponsors and Collaborators

  • Aalborg University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Julie Jepsen Strøm, MD, PhD Student, Aalborg University
ClinicalTrials.gov Identifier:
NCT04711031
Other Study ID Numbers:
  • 194-1
First Posted:
Jan 15, 2021
Last Update Posted:
Apr 20, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 20, 2021