跳至主要内容
临床试验/NCT02889055
NCT02889055终止不适用

Evaluation of Mirus™ for Sedation in Resuscitation

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2016年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
9
试验地点
1
主要终点
ead-time (in minutes) of sevoflurane sedation for obtaining a target RASS score between 1 (anxious) and 2 (mild sedation).

研究概览

简要总结

Current recommendations for the conduct of sédationanalgésie ICU encourage the use of the lightest possible sedation strategies, avoiding the administration of benzodiazepines source of longer durations of ventilation and ICU stay of syndrome cessation, mental confusion. Among the proposed alternatives, administration of halogenated volatile agents (sevoflurane) in resuscitation is interesting because their favorable pharmacokinetic even after prolonged administration: no tachyphylaxis, rapid clearance, no withdrawal syndrome.

There are two suitable delivery devices sevoflurane in intensive care, both with CE marking. The device Mirus ™ (Pall Medical, Fribourg, Switzerland) is the newest and it is easy to use and reliable. The objective of this study was to evaluate the use of Mirus ™ device in trauma resuscitation and cardiovascular resuscitation.

Specifically, it will use this modality in case of failure with conventional sedation products (propofol, midazolam): maximum permissible doses, sedation weaning failure due to severe agitation.

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

入选标准

  • Patients aged over 18 years
  • In mechanical ventilation for more than 48 hours
  • No intracranial hypertension
  • In severe state of agitation measured by a sedation scale score greater than 2 RASS
  • Agitation observed in two circumstances: receiving maximal doses of propofol (≥ 5 mg / kg / h) and / or midazolam (≥ 0.2 mg / kg / h), or weaning failure to stop the sedation agitation.

排除标准

  • Presence of a severe head injury (Glasgow initial score between 3 and 8) requiring monitoring intracranial pressure and / or treatment of intracranial hypertension
  • Sedation with dexmedetomidine
  • Personal or family antecedent of anesthetic malignant hyperthermia
  • Pregnant woman

结局指标

主要结局

ead-time (in minutes) of sevoflurane sedation for obtaining a target RASS score between 1 (anxious) and 2 (mild sedation).

时间窗: 24 hours

次要结局

未报告次要终点

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验