NCT01797250已完成不适用
Neonatal and Pediatric Studies Using a Bedside Respiratory Patient Monitoring System With the Functional Patient Monitoring PCBA-1
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- SpO2 Accuracy (percentage of blood oxygen saturation)
研究概览
简要总结
To determine accuracy specifications of the pulse oximeter in the NEO/PEDS subject population
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject or legal guardian is willing and able to sign informed consent prior to study initiation.
- •Subject is able to participate for the duration of the evaluation. In most instances, the length of the study will not exceed twenty-four hours.
- •Subject satisfies a specified sensor requirement (see Table 1).
- •Requires use of an intra-arterial line for medical reasons such as continuous blood pressure monitoring or frequent arterial blood draws.
- •Subject is able to accommodate multiple sensors.
- •Neonatal subjects up to 1 month of age or Pediatric subjects 1 month up to 18 years old.
排除标准
- •Subjects that have an existing health condition, in which the investigators determine that safe or accurate oximetry measures may not be obtained at the areas where the pulse oximetry sensor could be placed, will not be included in the study. For example, anyone with burns, 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.
- •Subject has severe contact allergies that may react to standard adhesive materials found in pulse oximetry sensors.
- •Subject cannot be reliably monitored with a pulse oximeter as a result of inadequate pulsatile signals.
- •Subject has had a procedure using injected intravascular dyes within 24 hours preceding testing
结局指标
主要结局
SpO2 Accuracy (percentage of blood oxygen saturation)
时间窗: Planned duration of study was up to 12 months. Duration of subject participation: 1-24 hours
次要结局
未报告次要终点
研究者
研究点 (2)
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