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临床试验/NCT05568849
NCT05568849尚未招募不适用

Optical Coherence Tomography Angiography (OCTA) to Assess Cardiac Output and Cerebral Perfusion at the Time of Children's Cardiac Surgery

Great Ormond Street Hospital for Children NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
2
主要终点
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

研究概览

简要总结

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.

详细描述

• OBJECTIVES

  1. To undertake a pilot study in young children undergoing cardiothoracic surgery to treat congenital heart disease involving cardiopulmonary bypass (CPB) at Great Ormond Street Hospital for Children (GOSH) in which OCTA images will be collected.
  2. To evaluate any practical barriers to acquiring OCTA images from children around the time of their heart surgery at GOSH, ensuring that the conduct of the anaesthetic and surgery are not disturbed.
  3. To process and review de identified OCTA images to see whether or not they provide potentially meaningful clinical data about peri-operative changes in cardiac output and cerebral perfusion for children undergoing surgery with CPB.

• HYPOTHESES

  1. It is feasible to use OCTA to obtain images that can be used to examine regional neuronal microcirculation and better understand peri-operative cerebral blood flow at stages before, during and immediately after cardiopulmonary bypass.
  2. There will be detectable, reproducible changes in OCTA readings at different states; pre-CPB, during and post-CPB and that these changes will be reflective of cerebral blood flow at these times.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: 1-3 hours

Feasibility measure

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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