Philips FAST SpO2 Technology With Masimo Sensors for SpO2 Monitoring in the Neonatal, Infant, and Pediatric Populations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The acceptability of the quality of SpO2 signal obtained during non-invasive oxygen saturation monitoring using Philips FAST SpO2 technology with Masimo neonatal, infant, and pediatric sensors. Accuracy root mean square (ARMS) will be calculated.
研究概览
简要总结
The objective of this study is to verify the form, fit and function of the Philips FAST technology with Masimo neonatal, infant and pediatric sensors for SpO2 monitoring in the respective indicated populations. The study design uses convenience sample data collection from neonatal, infant, and pediatric sensors within their respective indicated patient populations that have a range of different skin pigmentations, simultaneously with an FDA cleared pulse oximeter as a comparator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- 是
入选标准
- •Subject falls within the indicated population for the Philips FAST SpO2 Monitor with the Masimo sensor.
- •Subject is less than 22 years of age (pediatric subject per US FDA definition).
排除标准
- •Subject has a skin condition or deformity at the planned sensor application site, which would preclude sensor placement and measurements as standard of care (e.g., psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown).
- •Confounders of pulse oximetry per sensor direction for use (DFU).
- •Subject with distinct geographic variances in skin pigmentation (e.g., vitiligo), where the sensor is applied.
- •Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors.
- •Subject with nail polish or acrylic nails on the digits where sensor needs to be applied, who opts to not remove it.
- •Subject with known allergic reactions to adhesive tapes.
- •Subject is not suitable for the investigation at the discretion of the clinical research team.
研究组 & 干预措施
Masimo Sensors (RD SET and/or LNCS) connected to Philips Monitors using Philips FAST SpO2 Algorithm
All subjects are enrolled into this arm. All subjects will have blood oxygen measurements from:
- non-invasive Masimo Sensors (RD SET and/or LNCS) connected to Philips Monitors using Philips FAST SpO2 Algorithm for blood oxygen measurements and
- Masimo RD SET sensors connected to FDA-cleared pulse oximeter
干预措施: Masimo Sensor (RD SET and/or LNCS) connected to Philips Monitor using Philips FAST SpO2 Algorithm (Device)
结局指标
主要结局
The acceptability of the quality of SpO2 signal obtained during non-invasive oxygen saturation monitoring using Philips FAST SpO2 technology with Masimo neonatal, infant, and pediatric sensors. Accuracy root mean square (ARMS) will be calculated.
时间窗: 45 minutes
次要结局
- The acceptability of the fit of sensor by visual observation of the emitter and detector alignment.(45 minutes)