跳至主要内容
临床试验/NCT03488238
NCT03488238已完成不适用

Correlation of Changes in PaO2 and ORi in Adult Patients

Masimo Corporation2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
2
主要终点
Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.

研究概览

简要总结

The Oxygen Reserve Index (ORi) is a reference that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi of 0.00 corresponds to PaO2 values of 100mmHg and below and an ORi of 1.00 corresponds to PaO2 values of 200mmHg and above. This is a prospective, non-blinded, non-randomized study of the Oxygen Reserve Index (ORi) in a clinical setting. It is designed to evaluate the correlations with ORi and changes in PaO2 and the potential use of ORi as an early warning of impending arterial oxygen desaturation.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than 18 years
  • ASA physical status III or IV
  • Scheduled for an elective surgical procedure requiring endotracheal intubation and the use of an arterial pressure monitoring catheter placed prior to induction of general anesthesia

排除标准

  • Age less than 18 years
  • Adults unable to give primary consent
  • Pregnancy
  • Prisoners

结局指标

主要结局

Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.

时间窗: Less than 30 minutes

ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore concordance is calculated to evaluate changes in ORi relative to the changes in PaO2.

Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.

时间窗: Less than 30 mins

ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity is calculated to evaluate changes in ORi relative to the changes in PaO2.

Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.

时间窗: Less than 30 mins

ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore specificity is calculated to evaluate changes in ORi relative to the changes in PaO2.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验