Utilization of Confocal Microscopy During Cardiac Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced Adverse Events Possibly Related to Study Intervention
研究概览
简要总结
The investigators propose to translate confocal microscopy for use during open heart surgery. This tool will help discriminate between various types of tissues in the heart during surgery. One of the most feared complication after heart surgery is heart block. This flexible fiberoptic confocal microscope will help discriminate between the various types of tissues in the heart and thus help avoid injury to the conduction tissue during surgery.
详细描述
This is an interventional pilot study that proposes to evaluate the safety, logistical feasibility, and technological feasibility of using Fluorescite with fiberoptic confocal microscopy during cardiac surgery to discriminate between cardiac tissue and conduction tissue. During surgery to repair atrial septal defect, diluted Fluorescite will be added to the surface of the heart. The fiberoptic confocal microscope (Cellvizio 100 Series System with Confocal Miniprobe) will be used to record images in several different locations of the heart. The image files will be provided to blinded raters who will attempt to identify whether they contain cardiac tissue or conduction tissue. All subjects will be monitored while they are inpatient after surgery for any adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Days 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between 30 days and 21 years old
- •Undergoing elective surgery for closure of atrial septal defect
- •Both parents attend pre-operative clinic appointment, to provide 2 parent consent, or an adult participant (age 18-21) may provide consent for him/herself
排除标准
- •Prior history of adverse reaction to fluorescein sodium
- •Prior history of renal failure or abnormal renal function
- •Baseline PR interval > 220 msec or 98% for age
- •Baseline HR > 87% for age
- •Underlying genetic syndrome associated with progressive AV block of sinus node dysfunction (e.g. Holt-Oram or NKX2.5)
研究组 & 干预措施
Imaging arm
Up to 5mL of 1:1000 dilute FLUORESCITE will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes
干预措施: Fluorescite (Drug)
Imaging arm
Up to 5mL of 1:1000 dilute FLUORESCITE will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes
干预措施: Cellvizio 100 Series System with Confocal Miniprobes (Device)
结局指标
主要结局
Number of Participants Who Experienced Adverse Events Possibly Related to Study Intervention
时间窗: Surgery through discharge (approximately 5 days)
All adverse events will be collected and relatedness to study intervention will be determined.
次要结局
- Percentage of Agreement in Classification of FCM Images(After all participants completed the study (range 2 months to 1 year post surgery))
- Number of Participants For Whom FCM Imaging During Cardiac Surgery Was Feasible(Surgery through discharge (approximately 5 days))
研究者
Aditya Kaza
Associate in Cardiac Surgery
Boston Children's Hospital