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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Katherine
Brown
katherine.brown@gosh.nhs.uk
Dr
Katherine
Brown
katherine.brown@gosh.nhs.uk
Other and unspecified disorders of the circulatory system
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Around 3500 children including 1,000 babies a year in the UK require heart surgery. Open-heart repairs involve the heart being stopped, while blood is pumped around the body using a cardiopulmonary bypass machine. Following complex operations, the patient may temporarily develop poor heart function, leading to reduced organ blood supply. Low heart output leads to post-operative complications or even death. The current methods to assess cardiac output and to see if vital organs, especially the brain, are receiving enough blood flow, are indirect and can be inaccurate. If we find a better way to detect and then avert or ameliorate periods of poor cardiac output and / or reduced brain perfusion, then this would be helpful for clinicians and could lead to better outcomes for children.
We believe that optical coherence tomography angiography (OCTA), a non-invasive way to image the blood vessels in the retina at the back of the eye, could help us to assess cardiac output and brain perfusion. The OCTA machine was approved for use in humans in 2019 and given a CE Marking, but it has previously been used mainly in the management of eye diseases. There is a small amount of experience with its use in critically ill adults. We plan a pilot study to see if it is possible to use the OCTA machine at key time points, before, during and after children's heart operations, in 30 patients. We will study the images taken with OCTA machine to see if they are of good quality and we will analyze the images to see whether or not the expected changes in cardiac output and brain perfusion that occur with heart surgery can be detected as changes in blood flow in the back of the eye. Depending on the success of this pilot, we will plan further studies.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Imaging;
You can take part if:
You may not be able to take part if:
Exclusion criteria - we will exclude all groups that are at risk from eye drop side effects as well as children who are unstable before surgery • Patients undergoing emergency or salvage surgery. • Patients who are clinically unstable prior to the operation. • Patients with known hypersensitivity to tropicamide drops or to any ingredient in its formulation. • Patients with known hypersensitivity to phenylephrine drops or to any ingredient in its formulation. • Patients with known high intra-ocular pressure or personal or family history of glaucoma. • Patients who are taking any of the following medications which may interact with phenylephrine eye drops: anti-hypertensive medications, monoamine oxidase inhibitors, tricyclic antidepressants, cardiac glycosides or quinidine.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS FOUNDATION TRUST and funded by Paediatric Critical Care Society .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 53790
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