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临床试验/NCT02907255
NCT02907255已完成不适用

Vital Sign Monitoring With Continuous Pulse Oximetry and Wireless Clinician Notification After Surgery

McMaster University1 个研究点 分布在 1 个国家目标入组 2,512 人开始时间: 2010年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2,512
试验地点
1
主要终点
Incidence of rescue respiratory resuscitations and ICU Transfers

研究概览

简要总结

Patients are at risk of respiratory depression after having surgery. The medications that patients are treated with to control their pain can impair their breathing and this can progress to respiratory and cardiac arrest and even death. Vital signs assessment on surgical wards is usually done every 4 hours and this may be insufficient to identify and manage many cases of respiratory depression. The aim of this study is to determine the impact on safety and nursing workflow of a respiratory monitoring on two surgical wards by measuring safety outcomes. Respiratory depression is a serious complication of pain treatment that can lead to patient complications and death. The level of monitoring available in hospitals by nursing staff is insufficient to manage this problem. If this new monitoring technology works as designed then patient safety can be improved while maintaining effective pain therapy.

详细描述

Patients are at risk for respiratory depression in the perioperative period. The opioids used in both patient controlled analgesia (PCA) and epidural analgesia can cause respiratory depression. The progression of opioid side effects usually starts with sedation, respiratory depression follows and, if left uncorrected, this can lead to respiratory and then cardiac arrest and death. Sedation is a common side-effect, occurring in about 13% of patients and the incidence of respiratory depression varies depending on the precise definition used and the analgesia modality, but it has been reported to occur in about 1% of cases. If you continuously monitor patients with oximetry and capnography the incidence of respiratory depression has been shown to be much higher, as high as 12%8. The incidence of cardiac arrest and death from opioid overdose has been estimated at about 2 cases per 10, 0009. Given that the number of patients undergoing surgery annually is about 100 million worldwide, respiratory depression occurs between 1 and 12 million times and it results in about 20, 000 preventable deaths each year10. The troublesome aspect of this complication is that it often occurs in healthy patients where the family and clinical staff do not anticipate a bad outcome.

The problem of unexpected respiratory depression amongst patients treated with opioids is compounded by the challenge of dealing with obstructive sleep apnea patients in the perioperative period. Obstructive sleep apnea, characterized by the complete or partial obstruction of the upper airway during sleep, is not rare, with about 25% of the general population (and a greater proportion of the surgical population) being at risk for this condition. These patients are at even greater risk of perioperative respiratory events and consequently the guidelines from the American Society of Anesthesiology recommend continuous monitoring of these patients13,14. These guidelines are expert-based as no clinical trials have established the efficacy of continuous monitoring in this population.

These two problems (respiratory depression from opioids and obstructive sleep apnea) have caused significant logistic problems in hospitals as many institutions do not have the equipment to provide continuous monitoring of patients outside of the intensive care units and there is limited capacity in the critical care areas to monitor all the patients at risk.

The impact of respiratory depression can be mitigated if it is recognized early enough and appropriate actions are taken to resuscitate the patient. Early recognition of this complication depends on frequent and regular vital sign assessments by nursing staff.

he problem in many surgical wards is that nursing staff, particularly at night, are spread thin and patients can occasionally go several hours without being seen. In this a period a patient can spiral into trouble from sedation to respiratory depression and eventually into respiratory and cardiac arrest. Previously, cardiac monitoring with telemetry has been available and could be used for patients in the perioperative period. Although telemetry has been proven useful for some groups of patients (including those with an automated defibrillator that has fired, those with a prolonged QT interval and those with acute heart failure) this technology will only pick up cases of respiratory depression that progress into a cardiac event15.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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
否

入选标准

  • •All surgical admission to wards E4 and F4 at Juravinski Hospital in Hamilton, Ontario, Canada

排除标准

  • •Patient's refusal to be monitored

研究组 & 干预措施

Oximetry monitor

Experimental
  • Standard care plus

  • Wireless respiratory monitoring

  • Covidien

  • Alarm triggers:

SpO2 ≤89% (heart rate) HR < 50 or > 120

干预措施: Oximetry monitor (Device)

Standard of Care

No Intervention

• Standard care:

  • 1:4 patient to nurse ratio
  • Vital signs every 4 hours
  • Respiratory rate and sedation scores every 2 hours for patients on the Acute Pain Service

结局指标

主要结局

Incidence of rescue respiratory resuscitations and ICU Transfers

时间窗: 3 days

Incidence of respiratory resuscitations and ICU transfers will be displayed as box plots and expressed as an odds ratio with 95% confidence intervals. The primary outcome (respiratory resuscitations) will be collected through the existing hospital administrative systems: the Acute Pain Service records, Naloxone administration for respiratory depression and the Department of Critical Care records all Code Blues and ICU transfers.

次要结局

  • Monitor acceptance rate by patients(3 days)
  • Impact on nursing workflow(3 days)
  • Risks factors for alarm events(3 days)
  • Number of alarms per patient per day(3 days)
  • Type (true or false alarms) and duration of alarms(3 days)
  • Response to alarm by nursing staff(3 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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