SPY Imaging System: Its Role in Pediatric Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
The current method of evaluating the surgical repair during surgery is limited to echocardiography (a noninvasive diagnostic procedure that uses ultrasound to study the structure and motions of the heart) or an invasive procedure called cardiac catheterization.
The SPY imaging system makes use of the fluorescence properties of indocyanine green (ICG) to obtain high quality images in blood vessels. ICG is a green dye used to test heart output. The use of the SPY imaging system during surgery may provide valuable information regarding successful vessel connection and the area remaining unblocked.
This study will compare the results of images to echocardiography and conventional angiography results.
With SPY imaging, congenital heart surgeons would be able to check the quality of the procedure and revise, redo or perform additional procedures as dictated by the images before the patient leaves the operating room.
详细描述
It would be advantageous to detect potential problems with vessel and anastomotic patency prior to leaving the operating room. The SPY imaging system makes use of the fluorescence properties of Indocyanine Green (ICG) to obtain high quality images of blood vessels. Unlike conventional angiography, indocyanine green fluorescence imaging offers the potential for a reliable, non invasive, inexpensive and rapid method of intraoperative assessment of vessel and anastomotic patency.
This type of imaging resource could be invaluable in a repair such as:
- coronary artery re-implantation following arterial switch procedure for transposition of the great arteries, anomalous coronary artery from the pulmonary artery repair, or aortic root replacement,
- coarctation of the aorta,
- Blalock-Taussig shunt, right-ventricle-to-pulmonary artery shunt, or cavopulmonary connection for single ventricle palliation, and
- branch or distal pulmonary artery reconstruction/unifocalization in tetralogy of Fallot and pulmonary atresia/ventricular septal defect.
The SPY imaging system is feasible for a variety of congenital heart defects and can provide valuable information regarding vessel and anastomotic patency.
Specific Aim 1: Evaluate quality of images for clarity and ability to visualize desired anatomic area
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing congenital heart operations at Children's Healthcare of Atlanta.
- •Less than or equal to 18 years of age.
- •Arterial switch procedure
- •Anomalous coronary artery from the pulmonary artery repair
- •Aortic root replacement
- •Coarctation of the aorta repair
- •Blalock-Taussig shunt
- •Right ventricle-to-pulmonary artery shunt
- •Cavopulmonary shunt
- •Branch or distal pulmonary artery reconstruction
- •Unifocalization of aortopulmonary collaterals
排除标准
- •Known sensitivity to ICG, iodides or shellfish
- •Inability to obtain informed consent
- •> 18 years of age
研究者
Brian Kogon
Associate professor, surgery
Emory University