Improved Patient Safety Through Continuous Bi-channel Respiratory Rate and Oxygen Saturation Monitoring With Masimo Patient SafetyNet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Improved sensitivity of RRa by detecting the number and the incidence rate of respiratory depression events
研究概览
简要总结
The investigator intend to perform an observational study, by adding Respiratory Rate monitoring to an already existing Patient SafetyNet system with SpO2 (Oxygen Saturation) and PR (Pulse Rate) monitoring. RRa will be blinded to the clinicians and all RRa alarms will be deactivated. Retrospective analysis of the observational data collected will be utilized to evaluate the potential benefits of additional continuous respiratory rate monitoring.
详细描述
Addition of acoustic respiratory rate monitoring to an already existing standard of care patient surveillance system that includes oxygen saturation and heart rate monitoring by pulse oximetry will result in earlier and more sensitive detection of respiratory events and possibly early stages of developing sepsis in a post-surgical/orthopedic study population.
An observational study with RRa is an additional blinded parameter to the already existing standard of care monitoring with SpO2 and PR on one post-surgical floor, (includes Trauma and orthopedic patients), where patients receive opioids for pain management. 300 consecutive patients will be enrolled and monitored with RRa for at least the first 24hours post-surgery, after discharge from the Recovery Room, & upon admission to the Surgical floor.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •• Adult 18yrs of age or older
- •Post-surgical patient receiving opioid pain medication
排除标准
- •• Refusal of optical finger sensor and/or acoustic respiratory rate neck sensor placement
- •Finger or skin abnormalities at sensor sites
- •Expected opioid therapy duration less than 24 hours
结局指标
主要结局
Improved sensitivity of RRa by detecting the number and the incidence rate of respiratory depression events
时间窗: with in 24 hours post surgery
次要结局
- Time period between detection of first early symptoms of developing sepsis with RRa, PR and SpO2 monitoring compared to the first clinical diagnosis of developing sepsis.(with in 24 hours post surgery)