NCT00939224已完成不适用
Calibration and Validation of the a Non-Invasive Regional Oxygen Saturation Device in Neonates, Infants and Children Undergoing Cardiac Catheterization
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- The success of the validation and calibration will be assessed through the Arms statistic.
研究概览
简要总结
The purpose of this study is to validate the Nonin Near-infrared spectroscopy (NIRS) device to measure regional oxygen saturation in a cohort of children with cardiovascular disease undergoing cardiac catheterization.
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
- — 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is male or female;
- •The subject is of any racial or ethnic group;
- •The subject is between 0 days and 12 years of age;
- •Is less than 40 kg;
- •The subject is scheduled for a cardiac catheterization for treatment or diagnosis of a cardiovascular disease;
- •The scheduled cardiac catheterization includes catheter placements in the central venous circulation and central arterial circulation, or catheter placement in the central venous circulation with a pre-existing arterial catheter;
- •The subject is American Society Anesthesiologist (ASA) status 1 through 4; and
- •The subject's legally authorized representative has given written informed consent to participate in the study and, when appropriate, the subject has given assent to participate.
排除标准
- •Is greater than twelve (12) years of age;
- •Has pre-existing allergies to adhesive tapes or adhesives on neonatal ECG pads;
- •Has pre-existing skin condition at the site where the Nonin cerebral oximeter sensor will be placed (e.g., eczema, dermatitis);
- •Has craniofacial disease preventing application of the sensor to the forehead;
- •Has sickle cell anemia or other hemoglobinopathy;
- •Has disease of the cerebrovasculature including the jugular or carotid vessels;
- •Was previously on ECMO involving the carotid or jugular vessels that could have resulted in disease or ligation;
- •Is not able to be in a supine position with cardiac catheterization laboratory table angle zero degrees with a neutral neck position at zero degrees rotation;
- •Has acute neurological injury (seizure, stroke, encephalopathy, meningoencephalitis currently or within the past 10 days), or a structural brain lesion (eg, arteriovenous malformation, cyst) in the optical field beneath the sensor;
- •Has an emergency, life-threatening condition (American Society of Anesthesiologists Physical status 5 or 6) impacting the ability to obtain informed consent;
- •Or has another condition, which in the opinion of the principal investigator would not be suitable for participation in the study.
结局指标
主要结局
The success of the validation and calibration will be assessed through the Arms statistic.
时间窗: Single visit
次要结局
- Tissue (somatic) sensor readings will be described using the descriptive statistics.(Single Visit)
研究者
研究点 (3)
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