None listed
Conditions
Brief summary
The primary purpose of this study is to determine the diagnostic accuracy of a nurse performed shortened heart scan protocol to detect severe heart defects in newborn infants 30 days of life or less. The study team hypothesise that the nurse performed shortened heart scan can accurately detect severe heart defects in newborns 30 days of age or less.
Interventions
The intervention is a Nurse performed focused cardiac ultrasound protocol. The focused cardiac ultrasound protocol includes 5 transthoracic views and has been developed based on fetal and postnatal echocardiogram techniques.
A minimum of 5 Senior Nurses (Clinical Nurse Specialists, Associate Nurse Unit Managers, Clinical Educators and Nurse Practitioners) within a Tertiary Neonatal Intensive Care Unit will be provided training and support to perform the study intervention. The teaching comprises
The intervention is a Nurse performed focused cardiac ultrasound protocol. The focused cardiac ultrasound protocol includes 5 transthoracic views and has been developed based on fetal and postnatal echocardiogram techniques. A minimum of 5 Senior Nurses (Clinical Nurse Specialists, Associate Nurse Unit Managers, Clinical Educators and Nurse Practitioners) within a Tertiary Neonatal Intensive Care Unit will be provided training and support to perform the study intervention. The teaching comprises of a learning module which takes approx 4 hours to complete and provides basic ultrasound principles, the cardiac views relevant to the study, ultrasound machine care and study document information. This will be followed by approx 5 simulation sessions of up to 1hr and 10 supervised practical sessions with PI or cardiac sonographer. Final sign-off of competence will be assessed by a cardiac sonographer or cardiac fellow. The Nurse performed focused cardiac ultrasound protocol will only be performed once on recruited participants and will take a maximum of 15mins to complete. The study intervention will be documented in the electronic medical record of the patient as well as any adverse events. The Primary Investigator will access all study intervention images to ensure each patient has a completed study protocol before images are uploaded to a secure organisational network folder for review by 2 cardiologists.
Sponsors
University of Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 30 Days
Healthy volunteers
No
Inclusion criteria
- Newborn infants 30 days of life or less - Having an inpatient echocardiogram as part of their illness work-up. - Parental or legal guardian consent.
Exclusion criteria
- Major congenital anomaly, other than potential congenital heart disease, that may prevent a focused cardiac ultrasound from being performed or harm may be caused by performing the ultrasound. - Life threatening situations where performing the focused cardiac ultrasound may destabilise the patient further. - Cardiac surgery.
Outcome results
None listed