Spectroscopic Assessment of Myocardial Oxygenation Changes in Pediatric Heart Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Ability to observe/monitor changes in myocardial oxygen availability
研究概览
简要总结
The goal of this observational study is to investigate the ability of the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor to observe and monitor changes in cardiac oxygen availability in pediatric patients during open-heart surgery.
Patients of less than 18 years old who, and whose guardian(s), when applicable according to national legislation, have signed the informed consent, can participate in the study.
The primary hypothesis is that the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor can detect myocardial oxygen availability in pediatric open-heart surgery patients. It is expected that the detected tissue oxygenation timely correlates with procedures affecting myocardial perfusion and other clinical parameters during the operation.
The secondary hypothesis is that the SpectroCor Tissue Oxygenation Monitor and its accessory, the SpectroCor Sensor, are safe to use, and their usability is acceptable.
No comparison group is included in the study.
The devices are used by the study investigators during open-heart surgery to collect myocardial tissue spectrometer data from the pediatric population to validate and potentially further develop the monitor and its accessory, the sterile sensor. The follow-up period for each participant ends with discharge from the hospital. No data (such as questionnaires) are obtained directly from the study participants.
详细描述
This is a single-center study. Thirty participants, less than 18 years old, with planned elective open-heart surgery, will be recruited for this study. The primary purpose is to investigate the ability of the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor to observe and monitor peripheral tissue oxygenation perioperatively. This open, non-controlled observational study aims to assess the monitor's ability, in combination with the sensor, to monitor and observe tissue oxygenation and the safety of the device in routine clinical practice, reflecting the real-world patient population and treatment scenarios. Therefore, no control group is needed.
For this clinical investigation, pediatric age groups will be defined according to the ICH E11/EMA framework (neonates: 0-28 days; infants: 1-23 months; children: 2-11 years; adolescents: 12-17 years). Although these definitions originate from medicinal product regulation, they are widely accepted and provide a consistent basis for pediatric clinical research.
There is currently no separate international classification system specific to medical devices. However, the ICH E11/EMA framework is appropriate for device investigations because it reflects physiological differences in growth and development that are directly relevant to cardiac surgery and to the intended uses of the monitor and sensor. In particular, the greatest physiological differences compared to adults are found in neonates and infants, where cardiac size, myocardial composition, and perioperative risks differ substantially.
The study, therefore, aims to include patients across the pediatric spectrum with emphasis on neonates and infants, while allowing flexibility in recruitment numbers. Data from older children and adolescents can be reasonably bridged to adult data, given similarities in cardiac anatomy and physiology. This approach ensures that safety and usability are adequately assessed across the relevant pediatric subpopulations without imposing rigid subgroup quotas, which would be impractical in this rare and heterogeneous patient population.
Primary endpoint:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for open-heart surgery.
- •Signed informed consent
排除标准
- •Inability to provide informed consent
结局指标
主要结局
Ability to observe/monitor changes in myocardial oxygen availability
时间窗: Intraoperatively, from sensor insertion to removal; typically 1 to 6 hours.
Proportion of monitor-sensor applications demonstrating expected myocardial oxygenation response - percentage of applications in which the device detects a decrease in Hb/Mb saturation and CcOx oxidation after aortic cross-clamping, an increase after de-clamping, and/or an increase after blood cardioplegia administration.
次要结局
- Incidence of device or protocol-related adverse device events and serious adverse device events(From informed consent through hospital discharge; assessed up to approximately 30 days)
- Incidence of device or protocol-related serious adverse events(From informed consent through hospital discharge; assessed up to approximately 30 days)
- Incidence of device defeciencies(From informed consent through hospital discharge; assessed up to approximately 30 days)
- Incidence of device or protocol-related adverse events(From informed consent through hospital discharge; assessed up to approximately 30 days)