Pulse Oximetry Performance Comparison in Newborns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- To compare time to stable signal of heart rate (HR) estimation between two pulse oximeters (PO).
研究概览
简要总结
The overall purpose is to directly compare pulse rate (PR) acquisition and oxygen saturation performance between two pulse oximeters (PO) in newborns.
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
- 29 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent or legal guardian is willing and able to provide informed consent prior to any study procedures being performed.
- •Subject is expected to be able to participate for the duration of the evaluation in the delivery room. In most instances, the length of the study will not exceed the anticipated duration of ECG monitoring.
- •Subject is ≥ 29 weeks gestational age.
- •Subject can accommodate multiple sensors.
排除标准
- •Subjects that have an existing health condition, in which the investigator determines that safe or accurate oximetry measures may not be obtained at the areas where the PO sensor could be placed. For example, major congenital anomalies, limb anomalies or anyone with abrasions or surface lesions on the contact areas would be excluded.
- •Any subject whose treatment or condition would be compromised if they were to participate in this study and any patient whose use of a pulse oximeter and sensor would present a potential for serious risk to health, safety, or welfare.
- •Currently participating in any other study expected to confound study results in the opinion of the investigator.
研究组 & 干预措施
Newborn
A variety of subjects will be targeted for inclusion representing differing stages of development and environments
干预措施: OxySoftN™ Neonatal-Adult SpO2 Sensor with N600X Nellcor™ Patient Monitoring System (Device)
Newborn
A variety of subjects will be targeted for inclusion representing differing stages of development and environments
干预措施: LNCS® NEO SpO2 Sensor with RAD-97™ Pulse CO-Oximeter (Device)
Newborn
A variety of subjects will be targeted for inclusion representing differing stages of development and environments
干预措施: 1041PTS (or similar) Kendall™ Neonatal Electrodes with IntelliVue MP5 Portable Patient Monitor (Device)
结局指标
主要结局
To compare time to stable signal of heart rate (HR) estimation between two pulse oximeters (PO).
时间窗: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
To compare overall accuracy of heart rate (HR) estimation between two pulse oximeters (PO) as compared to gold standard electrocardiography (ECG).
时间窗: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
次要结局
- To evaluate instances of false bradycardia.(Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.)
- To evaluate instances of false bradycardia requiring emergency medical treatment.(Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.)
- To evaluate variability in PR between the two PO sensors(Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.)
- To compare the number of repositions and replacements required for the two PO sensors during monitoring.(Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.)