跳至主要内容
临床试验/NCT01983800
NCT01983800已完成不适用

Use of Volatile Anesthetics for Long-Term Sedation In Critically Ill Patients

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
atmospheric volatile concentration

研究概览

简要总结

Heavy sedation or sleep is a common problem within the intensive care unit (ICU) using our standard intravenous medications. This commonly leads to confusion, low blood pressure, slow wake up and removal of the artificial breathing tube (extubation), which prolongs ICU stay. Using inhaled volatile anesthetic agents are likely to improve these patient outcomes. This unique project is the first North American study looking at using volatiles for patients who need longer-term ICU sedation. This project has excellent potential at lowering these complications and improving quality of care, which will lower patient ICU stay and healthcare costs.

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

  • adult ICU patients expected to be ventilated > 48 hours

排除标准

  • age < 18 years
  • history of malignant hyperthermia
  • propofol infusion syndrome
  • evidence of raised intracranial pressure
  • 6-month mortality risk from pre-existing condition > 50%
  • lack of commitment to maximal treatment
  • NebulizedFlolan
  • tidal volume <350ml
  • patients on one lung ventilation

研究组 & 干预措施

intravenous propofol/midazolam

Active Comparator

Sedation using intravenous propofol/midazolam, sedation will be titrated to a Riker Agitation Sedation Score

干预措施: Propofol/midazolam (Drug)

isoflurane

Active Comparator

Sedation using inhaled isoflurane, sedation will be titrated to a Riker Agitation Sedation Score

干预措施: Isoflurane (Drug)

结局指标

主要结局

atmospheric volatile concentration

时间窗: daily

Daily assessment of atmospheric volatile levels will be measured using photometric multigas infrared analyzer

Sedation

时间窗: daily

adherence to the volatile sedation, sedation will be guided by explicit protocols targeting a Sedation-Agitation Score (SAS) of 3-4

Feasibility

时间窗: 2 years

assess rate of patient recruitment and barriers to recruitment

Education Tool

时间窗: 2 years

multidisciplinary feedback regarding teaching package, protocol, quality of sedation

serum fluoride levels

时间窗: every 2 days

Measurements will be taken 24 hours post sedation and every 2 days until while on sedation followed by 2 further samples after discontinuation of sedation.

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 (2)

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