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临床试验/NCT04694599
NCT04694599Unknown不适用

The Effect of Continuous Pulse Oximetry Monitoring and Early Intervention Using Wearable Device on the Incidence of Postoperative Hypoxemia a Randomized Controlled Trial

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
94
试验地点
1
主要终点
The prevalence of prolonged hypoxemic episodes

研究概览

简要总结

Vital signs of postoperative patient are monitored intensively in post-anesthesia care unit or intensive care unit, but the frequency of surveillance decreases in typical surgical wards. The continuous pulse oximetry in surgical wards is known to be useful in detection and prevention of hypoxemia, reducing complications caused by postoperative respiratory depression. However, continuous monitoring is not conducted, due to shortage of equipment and personnel. Recently, wearable device for measuring pulse oxygen saturation, which is inexpensive, applicable to patients with mobility, and can be monitored continuously through wireless connection, has been supplied. In this study, the investigators evaluate the effect of continuous monitoring of oxygen saturation with wireless device(MASIMO Radius-7) on postoperative patients who are transferred to general wards, and evaluate the effect of early intervention in reducing the event of hypoxemia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing noncardiac surgery under general anesthesia
  • American Society of Anesthesiologists (ASA) physical status class I-III

排除标准

  • Patients refusing to participate in the study
  • Patients under emergency surgery
  • Patients who wearable device is not applicable
  • Patients scheduled to be transferred to intensive care unit
  • Patients scheduled to receive oxygen supplementation in surgical ward
  • Patients scheduled to undergo continuous pulse oximetry monitoring

结局指标

主要结局

The prevalence of prolonged hypoxemic episodes

时间窗: 24 hours after transfer to surgical ward

the prevalence of hypoxia lasting more than 1 hour, according to a threshold of SpO2\<90%

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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