PILOT STUDY: A Randomized Controlled Trial of Intensive Care Management of Sedation Using Patient Responsiveness in Critical Care IMPROVE Critical Care Study Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Proportion of time spent with low responsiveness (red colour code) during the first 48 hours in the ICU
研究概览
简要总结
The Pilot Clinical Investigation planned is a prospective, unblinded randomized pilot trial comparing sedation management using a protocol based on responsiveness with standard sedation management. The hypothesis is that responsiveness will improve a range of patient-based and economic outcomes, including the duration of mechanical ventilation and duration of coma in the ICU. The purpose of the pilot study is to gather information for designing a full study that might show the validity of the outcome hypothesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients mechanically ventilated via an endotracheal tube and receiving intravenous sedation with a hypnotic agent (midazolam or other benzodiazepine) or propofol by continuous infusion.
排除标准
- •Primary intracerebral disorder (includes cardiac arrest with probable hypoxic brain injury; intrac-ranial haemorrhage; head injury causing reduced conscious level prior to intubation)
- •Patient who is already awake at the time of enrolment defined as RASS ³ -1
- •Age <16 years
- •Patient not expected to survive the next 24 hours
- •Patient receiving long term ventilation prior to ICU admission
- •Patient with a long term tracheostomy prior to ICU admission
- •Patient transferred sedated and mechanically ventilated from another ICU unless recruitment is possible within 24 hours of first ICU admission
- •Patient receiving continuous neuromuscular blocking agent at the time of screening for enrolment
- •Previously enrolled in the trial during a separate ICU admission during this hospital stay
- •Status epilepticus
- •Confirmed meningitis or encephalitis at the time of screening for enrolment
- •Chronic neurological disease interfering with normal neuromuscular function, e.g. motor neurone disease, Guillain-Barre syndrome or inherited neuromyopathies
研究组 & 干预措施
Protocol
Using sedation monitoring and protocol
干预措施: "Sedation Trial Monitor" is the name of the device used. (Device)
Control
Standard practice
结局指标
主要结局
Proportion of time spent with low responsiveness (red colour code) during the first 48 hours in the ICU
时间窗: 8 month period
The main purpose in the statistical analysis is not to test the statistical significance of the differences but to provide descriptive statistics for the full outcome study plan.
次要结局
- Proportion of time spent with RASS score -4/-5 during the first 48 hours in the ICU.(8 months)