NCT06432881已完成不适用
Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 461
- 试验地点
- 1
- 主要终点
- Investigation of skin pigmentation effect on performance of Masimo pulse oximetry
研究概览
简要总结
The objective of this study is to evaluate the performance of Masimo RD SET® SpO2 sensors in subjects with light and dark skin pigmentation in the intensive care therapeutic area.
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
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18 years of age or older.
- •Subject is receiving care in an intensive care unit.
- •Subject with an arterial catheter in place.
- •Subject is experiencing hypoxemia as defined by 1) need for supplement oxygen or 2) peripheral oxygenation ≤ 94% on room air
排除标准
- •Subjects in whom pulse oximetry cannot be reliably performed on both the third and fourth digit on the hand ipsilateral to the arterial line, precluding application of the sensor (e.g., amputation and deformity).
- •Subjects with a skin condition affecting the digits, where the sensor is applied, which would preclude sensor placement as standard of care (e.g., psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.).
- •Subjects with distinct geographic variances in skin pigmentation (e.g., vitiligo) on the digit where the sensor is applied, which would preclude sensor placement as standard of care.
- •Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied.
- •Subjects with known allergic reactions to adhesive tapes.
- •Subjects with arterial catheter placed in a lower extremity.
- •Subjects not suitable for the investigation at the discretion of the investigator or the clinical team.
研究组 & 干预措施
RD SET Sensor
Experimental
All subjects are enrolled into this arm and will have Sp02 measurements obtained.
干预措施: RD SET Sensor (Device)
结局指标
主要结局
Investigation of skin pigmentation effect on performance of Masimo pulse oximetry
时间窗: Approximately 30 minutes
The study is designed to evaluate the performance of Masimo RD SET SpO2 sensors in subjects with light and dark skin pigmentation in the intensive care therapeutic area. SpO2 accuracy will be determined by calculating the ARMS value which will be reported as percent of oxygen saturated hemoglobin.
次要结局
未报告次要终点
研究者
研究点 (1)
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