Medtronic Accuracy Performance Verification of the INVOS™ System in the Pediatric Cardiac Catheterization Laboratory (INCATH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 5
- 主要终点
- Accuracy of the root mean square
研究概览
简要总结
Prospective, observational, multi-center trial designed to capture calibration and performance evaluation data with the INVOS™ system.
详细描述
The purpose of this study is to verify INVOS™ cerebral oximetry system performance in pediatric and infant patients bycomparing regional oxygen saturation (rSO2) values to reference blood oxygen saturation measurements obtained throughinternal jugular vein and arterial blood convenience sampling according to International Organization on Standards (ISO) 80601-2-85:2021.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Under 21 years of age
- •Meets weight requirement for sensors under study
- •Scheduled for a diagnostic or interventional cardiac catheterization procedure with general anesthesia or sedation
- •Arterial and venous access as part of the planned catheterization procedure
排除标准
- •Prior known severe allergies to medical grade adhesive/tape (Band-Aid) [self-reported]
- •A skin condition at the sensor site (e.g., rash, abrasion, laceration)
- •Craniofacial disease producing abnormal forehead anatomy and/or preventing forehead application of the sensor
- •A known structural brain lesion beneath the sensor
- •Known hemoglobinopathy
- •Inability to lie supine with neutral neck position during catheterization
- •Cerebrovascular disease
- •An emergent, life threatening condition impacting study conduct
- •Unwillingness or inability to sign informed consent (IC) or assent by the parents/guardians of child
- •Currently receiving phototherapy for bilirubin
- •Arterial or venous anatomy that would preclude obtaining an accurate paired sample
- •Known pregnancy
结局指标
主要结局
Accuracy of the root mean square
时间窗: At the point of blood sampling during cardiac catheterization procedure
root mean square of the difference in regional oxygen saturation (rSO2) as measured by the INVOS and field saturation (fSO2) as measured by blood sampling
次要结局
未报告次要终点