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临床试验/NCT00466492
NCT00466492已完成不适用

Advantages and Disadvantages of Long Term Sedation in ICU Patients

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2007年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
2
主要终点
Time receiving mechanical ventilation, total intensive care and hospital length of stay.

研究概览

简要总结

The purpose of the study is to determine whether sedation of the critical ill patient prolongs the time receiving mechanical ventilation.

详细描述

The golden standard is to sedate critical ill patients receiving mechanical ventilation with daily wake up trials. This is shown to reduce the time receiving mechanical ventilation compared to no wake up trials.

We would like to study whether no sedation but only analgesics administered as bolus doses, reduce the time receiving mechanical ventilation. The study is planned as a randomised prospective study, not blinded. The control group is patients receiving sedation with daily wake up trials. The intervention group is not sedated, but receives bolus doses of analgesics (morphine). The endpoint is the time spend receiving mechanical ventilation, lengths of stay on the intensive care unit, and total lengths of stay on the hospital.

We also examine the frequency of ventilator associated pneumonia and CT scans of cerebrum. Also we would like to examine the long term psychological effects of sedation, we plan to send some of the patients to a post traumatic stress screening. The effect on the next of kin we plan to study with a questionnaire. As a last thing we would like to study the workload on the nurses.

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

  • Intubated receiving mechanical ventilation
  • Expected to remain intubated more than 24 hours
  • Over 18 years

排除标准

  • Raised intracranial pressure
  • Treatment with muscle relaxants

结局指标

主要结局

Time receiving mechanical ventilation, total intensive care and hospital length of stay.

次要结局

  • The frequency of VAP, CTC. The amount of Post Traumatic Stress after 6 month. The patients families experience. The workload on the nurses(VAP and CTC during hospital stay. PTSD 1-2 years after the primary stay)

研究者

申办方类型
Other

研究点 (2)

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