None listed
Conditions
Brief summary
The RECARDINA project will evaluate two possible approaches to an innovative screening protocol for congenital and rheumatic heart disease (RHD) in school-aged children and young people, using briefly-trained healthcare workers conducting handheld, single view (SPLASH) echocardiography. Both approaches could potentially be scaled up to allow for screening very large numbers of children in a short period of time. The first approach is a screen and refer approach, whereby briefly-trained healthcare workers identify suspected abnormal scans, and refer these children on for further evaluation by a cardiologist; the second approach involves offsite expert review of all echo images obtained by the briefly-trained healthcare workers to identify which children have heart disease and require further follow up or treatment. The two approaches to screening will be evaluated in terms of diagnostic accuracy and which produces the highest yield of significant heart disease cases, in settings with limited resources and a high burden of undetected RHD. The Recardina study will take place in urban and rural sites in Timor-Leste and the Northern Territory.
Interventions
The index test is a SPLASH echocardiogram, conducted by a briefly trained health worker using a Lumify handheld ultrasound device (Philips Healthcare, USA). Brief training will be provided over a two-week course, involving lectures and practical teaching, with a minimum of 100 supervised echocardiograms, and successful completion of a written and practical assessment.
The health worker will obtain 2D and colour doppler images of the mitral and aortic valves, including a sweep in the parasterna
The index test is a SPLASH echocardiogram, conducted by a briefly trained health worker using a Lumify handheld ultrasound device (Philips Healthcare, USA). Brief training will be provided over a two-week course, involving lectures and practical teaching, with a minimum of 100 supervised echocardiograms, and successful completion of a written and practical assessment. The health worker will obtain 2D and colour doppler images of the mitral and aortic valves, including a sweep in the parasternal long axis plane. The echocardiogram will take approximately 5 minutes; in some cases up to 15 minutes. Any mitral regurgitation and/or aortic regurgitation will be measured in the longest plane, and the jet length measured in millimetres. All images will be stored as 6-second loops, and still images for jet length measurements. Any mitral or aortic regurgitation noted on SPLASH echocardiogram will be considered “abnormal” (screen positive). In the absence of any mitral regurgitation or aortic regurgitation, the SPLASH echocardiogram will be recorded as “normal” (screen negative). If the SPLASH echocardiogram is assessed as normal, the participant will be referred for a second SPLASH echocardiogram, conducted by an expert cardiac sonographer or cardiologist immediately after (on the same day). This echocardiogram will also take approximately 5 minutes. If the SPLASH echocardiogram performed by either the health worker or the expert is assessed as abnormal, or as having inadequate images to make a determination, the participant will be referred for cardiologist review and full screening echocardiogram immediately after (on the same day). The full screening echocardiogram will usually take 15-20 minutes, and if a cardiology review is required, this is likely to require a further 30 minutes. Later review of the SPLASH images, by an offsite expert, will allow for further analysis of two possible approaches to future implementation of screening: a health-worker led screen-and-refer approach, with a similar flow to what will happen in this study, or an approach where health-workers obtain screening echocardiogram images, that are reviewed and assessed remotely, to decide on onward referral and management.
Sponsors
Charles Darwin University
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
5 Years to 20 Years
Healthy volunteers
Yes
Inclusion criteria
All children and young people aged between 5 and 20 years present at the school or other screening site on the day of screening will be eligible to participate. Participants are eligible regardless of whether or not they have had a previous echocardiogram or are known to have heart disease.
Exclusion criteria
Children aged under 5 years, and adults aged over 20 years will be excluded. Participants and their guardians may choose to remove themselves from the study at any time.
Outcome results
None listed