Prospective Clinical Study of Pulse Oximeter Errors in Hospitalized Patients With Varying Skin Pigmentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 757
- 试验地点
- 1
- 主要终点
- Pulse Oximetry Errors
研究概览
简要总结
This is a prospective observational study designed to quantify and understand errors in pulse oximetry in hospitalized patients in relation to their skin pigmentation. It is driven by three recent retrospective studies showing missed diagnosis of hypoxemia in patients across a spectrum of skin pigmentation, defined as blood SaO2 <90% when their pulse oximeter reads 92% or greater.
详细描述
This prospective study will overcome the limitations of earlier retrospective studies using three important study protocols:
- precise time-matching paired blood gas samples to stable periods of pulse oximeter readings
- objective quantification of skin pigmentation rather than using documented or self-reported race
- collection of high quality pulse oximeter tracing data, and identifying potential mediators of discordance of noninvasive and invasive measurements such as low perfusion states.
The primary aim is to quantify the bias in SpO2 measurements across skin pigmentation groups in a real-world setting against the gold standard of invasive measurements of arterial blood oxygen saturation measurements across categories of skin pigmentation. These data are essential to addressing health equity and patient safety for people of all skin pigmentations.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •hospitalized and at high risk of hypoxemia, defined as saturations < 90%,
- •patients with arterial line in place for clinical purposes
排除标准
- •Profound anemia, defined as hemoglobin < 8 g/dl will preclude blood draws for research purposes
- •Known pregnancy
- •In custody of law enforcement officials
结局指标
主要结局
Pulse Oximetry Errors
时间窗: Up to 10 simultaneous, paired arterial blood samples and noninvasive pulse oximeter readings obtained during unpredictable qualifying episodes of low oxygen saturation identified by clinically indicated monitoring over a 14-day study period
Pulse oximeter bias (difference between SpO2 and SaO2)
次要结局
- Occult Hypoxemia Rates(Up to 10 simultaneous, paired arterial blood samples and noninvasive pulse oximeter readings obtained during unpredictable qualifying episodes of low oxygen saturation identified by clinically indicated monitoring over a 14-day study period)