Optical Coherence Tomography Angiography (OCTA) in Children's Cardiac Surgery

NCT05568849 | Unknown DMC

• 2 other identifiers: 21HL23314744 (Version 2.0)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Heart Disease; Children, Only

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the feasibility of taking at least two sets of good quality OCTA images per patient during the conduct of cardiac surgery

  Feasibility measure

  1-3 hours

Secondary Outcomes (2)

• The acceptability of the study procedures to members of the clinical care team based on a Likert rating scale.

  2-3 hours

• Change in blood flow measured in the retina by OCTA

  1-3 24 hours

Study Arms (1)

OCTA measurement arm

EXPERIMENTAL

There is only one arm in the study and patient care will not be changed. Additional measurements will be obtained over and above usual patient care in the OCTA measurement arm as detailed in the protocol.

Diagnostic Test: OCTA measurements

Interventions

OCTA measurements DIAGNOSTIC_TEST

OCTA images will be obtained from the retina at 1-3 time points around the time of children's heart surgery

OCTA measurement arm

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients undergoing elective surgery for congenital heart disease including both repair and palliation involving CPB.
• Patients under 10 years of age.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead
• University College, London: collaborator

Study Sites (1)

Great Ormond Street Hospital NHS Foundation Trust

London, WC1N 3JH, United Kingdom

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Katherine Brown, MD MPH

  Great Ormond Street Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Brown

CONTACT

+442078138180; katherine.brown@gosh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 6, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: March 1, 2024
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)