NCT03123328已完成不适用
Evaluation of Non-Invasive Hemoglobin in Trauma Patients Using FDA-Cleared Masimo Pulse CO-Oximeter
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 2
- 主要终点
- SpHb's Ability to Detect Critical Drops
研究概览
简要总结
This is a prospective, non-blinded, non-randomized, interventional study of the Masimo pulse oximeter and sensors in a trauma setting
详细描述
The study aimed to evaluate SpHb's ability to detect critical drops in a trauma population
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated 16 years of age or older or greater than or equal to 50 kg body weight if age unknown.
- •Level 1 (highest trauma activation) status at the time of arrival to emergency department (ED).
- •Expected to be admitted to the ICU/IMU for in hospital care.
排除标准
- •Moribund patients with devastating injuries and expected to die within one hour of ED admission.
- •Prisoners, as defined as those who have been directly admitted from a correctional facility (a free living individual who is under police observation as a suspect will remain in the study until hospital discharge).
- •Obvious pregnancy in the ED.
- •Received greater than 5 minutes of cardiopulmonary resuscitation (CPR) in the pre-arrival or hospital setting.
- •Has, on the ring, middle and index fingers of both hands, any of the following: finger deformities, injuries, including burns, scar tissue or infection, or any material that may interfere with sensor application or trans-illumination of the site.
- •Has significant bilateral trauma to the arms or forearms.
结局指标
主要结局
SpHb's Ability to Detect Critical Drops
时间窗: Up to 24 hours.
The ability of noninvasive continuous total hemoglobin (SpHb) to detect critical drops in arterial or venous hemoglobin values, calculated using chi-squared analysis.
次要结局
未报告次要终点
研究者
研究点 (2)
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