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临床试验/NCT00298493
NCT00298493已完成2 期

A Randomized Trial of Daily Sedative Interruption in Critically Ill Patients Being Managed With a Sedation Protocol - A Pilot Study

Mount Sinai Hospital, Canada2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2001年2月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
65
试验地点
2
主要终点
ICU and Hospital Lengths of stay

研究概览

简要总结

All critically ill, mechanically ventilated patients in the Intensive Care Unit receive medications to relieve pain and anxiety. However, accumulation of these medications can be associated with serious complications, most notably longer time on the breathing machine and in the ICU. Two strategies have been shown to dramatically improve patient outcomes: nurse-directed protocols for giving sedation, and daily interruption of sedation. However, these strategies have not been widely adopted, because of physicians' concerns, and because it is unclear which strategy is better. Given that patient outcome is improved with either of these strategies, the fundamental question that arises is whether patients managed with a combination of two strategies which both reduce drug accumulation (protocolized sedation and daily interruption) have an even better outcome than patients managed with only one of them (protocolized sedation). We propose a multicenter study in which 700 critically ill, mechanically ventilated patients will have their sedation managed with protocolized sedation alone, or both strategies. Both groups of patients will have the following recorded: ICU and hospital lengths of stay, mortality, total sedative drug use, ICU human resources used, side effects and recall of their ICU stay. The results of this large multi-center trial will help to inform best practice with regard to sedation management of critically ill patients in Canada and elsewhere. In addition, reducing ICU stay could be economically attractive, as the cost of an ICU day in Canada is approximately $3000.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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>18 years
  • Mechanically ventilated, with anticipated need for MV ≥ 48 hours
  • ICU team has decided to initiate continuous sedative/analgesic infusion(s)
  • informed consent.

排除标准

  • Admission after resuscitation from cardiac arrest
  • Traumatic brain injury
  • Currently receiving neuromuscular blocking agents
  • Allergy to any of the study medications
  • History of alcohol, sedative or analgesic abuse
  • History of psychiatric illness
  • Acute or chronic neurologic dysfunction
  • Administration of sedatives for >24 hr,
  • Lack of commitment to aggressive treatment
  • Current enrollment in a related trial
  • Previous enrollment in this trial.

结局指标

主要结局

ICU and Hospital Lengths of stay

Duration of Mechanical Ventilation

次要结局

  • Caregiver workload
  • Adverse events
  • Patient Recall

研究者

申办方类型
Other

研究点 (2)

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