Focused Lung Ultrasound: A Prospective Cohort Study in General Practice

Pneumonia Clinical Trial

Official title:

Focused Lung Ultrasound: A Prospective Cohort Study in General Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04711031
• Other study ID #: 194-1
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: June 5, 2022

Study information

• Verified date: August 2023
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: June 5, 2022
• Est. primary completion date: May 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• General Practice
• Pneumonia
• Respiratory Tract Infections
• Ultrasonography

Intervention

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.

Locations

Country	Name	City	State
Denmark	Center for General Practice at Aalborg University	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FLUS findings	Description of FLUS findings in patients with symptoms of acute LRTI in general practice where the GP suspects CAP.	2022
Secondary	Distribution of FLUS findings	Distribution of FLUS findings in each of the 14 scanning zones.	2022
Secondary	FLUS image quality	Proportion of FLUS examinations with acceptable image quality assessed by expert reviewers.	2022
Secondary	Agreement on FLUS findings	Level of agreement between GPs and expert reviewers on FLUS findings.	2022
Secondary	Unexpected events	Any unexpected events during the FLUS examination.	2022
Secondary	Clinical impact of FLUS	Clinical impact of FLUS on antibiotics prescription, working diagnosis, confidence in working diagnosis, plans for treatment and visitation.	2022
Secondary	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
Secondary	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
Secondary	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
Secondary	GP follow-up initiatives	Any GP follow-up initiatives within 28 days of follow-up.	2022