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临床试验/NCT07415187
NCT07415187招募中不适用

The Impact of Skin Tone on Pulse Oximeter Accuracy

Rush University Medical Center1 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2023年4月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
194
试验地点
1
主要终点
Difference between pulse oximeter oxygen saturation and arterial oxygen saturation

研究概览

简要总结

Pulse oximeters are widely used in hospitals to estimate blood oxygen levels using a sensor placed on the skin. Recent studies suggest that pulse oximeter readings may be less accurate in individuals with darker skin tones, which could delay recognition of low oxygen levels.

The purpose of this study is to evaluate the accuracy of pulse oximeters across a range of skin tones and to identify factors associated with differences between pulse oximeter readings and oxygen levels measured directly from blood.

This is an observational cohort study involving adult patients who are already undergoing an arterial blood gas (ABG) test as part of routine clinical care. The ABG test is not performed for research purposes and is not altered by participation in the study.

At the time the ABG sample is obtained, two commercially available pulse oximeters will be temporarily placed on the participant's finger to record oxygen saturation values. These readings will be compared with the oxygen saturation measured from the arterial blood sample. Pulse oximeter measurements collected for the study will not be used for clinical decision-making.

Skin tone will be assessed using both self-reported race/ethnicity and an objective, noninvasive skin pigmentation measurement device. This approach allows evaluation of the relationship between skin pigmentation and pulse oximeter accuracy.

Participation in the study involves minimal risk. No additional blood samples, medications, or treatments are required. The study does not alter standard medical care.

The findings from this study may improve understanding of pulse oximeter performance and help inform future efforts to reduce measurement bias and improve patient safety.

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

入选标准

  • Patients admitted to an intensive care unit, general medicine/surgery wards, or visiting the pulmonary function labs and/or outpatient pulmonary services clinics at Rush University Medical Center
  • Patient has an existing order for an arterial blood gas analysis [arterial line or puncture]

排除标准

  • Patients with heavy scar tissue on the sensor site
  • Patients with hand tremors
  • Opaque nail polish that cannot be removed

结局指标

主要结局

Difference between pulse oximeter oxygen saturation and arterial oxygen saturation

时间窗: At the time of clinically indicated arterial blood gas sampling (single time point)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brady Scott

Professor, Program Director

Rush University Medical Center

研究点 (1)

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