跳至主要内容
临床试验/NCT03021551
NCT03021551已完成不适用

Oxygen Reserve Index: Utility as Early Warning for Desaturation in Morbidly Obese Patients

Masimo Corporation2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年9月15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
80
试验地点
2
主要终点
Utility of ORi Providing Added Warning Time

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 partial pressure of oxygen (PaO2) values of 100 mmHg and below and an ORi of 1.00 corresponds to PaO2 values of 200 mmHg and above. This is clinical study designed to evaluate the clinical utility of the Oxygen Reserve Index (ORI) as an early warning for arterial hemoglobin desaturation during the induction of general anesthesia and tracheal intubation in obese patients undergoing elective surgical procedures.

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
  • BMI>30, <40 m/kg2
  • Control group only: BMI >18.5 m/kg2, <25 m/kg2
  • Scheduled for an elective surgical procedure requiring general anesthesia and endotracheal intubation
  • Exclusion Criteria
  • Age less than 18 years
  • Adults unable to give primary consent
  • Pregnancy
  • Prisoners

排除标准

  • 未提供

结局指标

主要结局

Utility of ORi Providing Added Warning Time

时间窗: 1 year

Evaluate the clinical utility of the change in the oxygen reserve index as an early warning of impending arterial oxygen desaturation in Obese patients (30 \< BMI \< 40 kg m-2) and Normal BMI patients (19 \< BMI \< 25 kg m-2).

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)

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