跳至主要内容
临床试验/NCT03043911
NCT03043911
已完成
不适用

Improved Patient Safety Through Continuous Bi-channel Respiratory Rate and Oxygen Saturation Monitoring With Masimo Patient SafetyNet

Baylor Research Institute1 个研究点 分布在 1 个国家目标入组 87 人2017年9月19日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Signs and Symptoms, Respiratory
发起方
Baylor Research Institute
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
状态
已完成
最后更新
2个月前

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.

注册库
clinicaltrials.gov
开始日期
2017年9月19日
结束日期
2021年11月10日
最后更新
2个月前
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

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)

研究点 (1)

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