Pneumonia Clinical Trial
Official title:
Focused Lung Ultrasound: A Prospective Cohort Study in General Practice
NCT number | NCT04711031 |
Other study ID # | 194-1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2021 |
Est. completion date | June 5, 2022 |
Verified date | August 2023 |
Source | Aalborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Center for General Practice at Aalborg University | Aalborg |
Lead Sponsor | Collaborator |
---|---|
Aalborg University |
Denmark,
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 |
Status | Clinical Trial | Phase | |
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