Clinical Performance of a Minimum Viable Prototype for Automated Closed-Loop Administration of Propofol for Deep Sedation in Patients on Invasive Mechanical Ventilation in Critically Ill Patient Units: a Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Infusion rate of propofol
研究概览
简要总结
The goal of this clinical trial is to evaluate a minimum viable prototype for automated closed-loop administration of propofol in deep sedated patients under invasive mechanical ventilation in the ICU. The main question it aims to answer is:
• whether the minimum viable prototype for automated closed-loop administration of propofol is effective in keeping patients in deep sedation using the lowest possible dose of propofol Participants will undergo deep sedation using the minimum viable prototype for automated closed-loop propofol administration.
The usual practice of sedation will be compared with the practice of sedating with the minimum viable prototype to see if the infusion rate of propofol is decreased
详细描述
The design of the study will consist of each patient being exposed to both forms of administration (matched pair study) during a 12-hour day (8:00 a.m. to 8:00 p.m.) in a randomized manner. Specifically, a patient will be given propofol infusion in open-loop mode in the first 5 hours (8:00 a.m. to 1:00 p.m.) and the next 5 hours in closed-loop mode (3:00 p.m. to 8:00 p.m.) with a wash-out period of 2 hours. The order will be randomly determined for each patient. This design will allow the use of the prototype to be evaluated under highly controlled conditions by a trained operator dedicated exclusively to this function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Indication of deep sedation for more than 48 hours
排除标准
- •Cranial surgery
- •Hypoxic-ischemic encephalopathy
- •Chronic liver damage Child C
- •History of substance and drug abuse that can alter EEG recordings or the metabolization of drugs (antipsychotics, cocaine, benzodiazepines, opioids)
- •Pregnant women
- •allergic to propofol
- •EEG sensor of the BIS® Covidien cannot be installed
研究组 & 干预措施
Control group
5-hour period in which patients will continue to be routinely sedated in the critical care unit
干预措施: Usual care (Device)
Experimental group
5-hour period in which patients will be sedated through the closed-loop system
干预措施: Minimum viable prototype (Device)
结局指标
主要结局
Infusion rate of propofol
时间窗: Fifth hour
mg/kg/h
次要结局
- Total dose of propofol(Five hours)
- Sedation level(Fifth hour)
- BIS level(Five hours)
- Suppression rate(Five hours)
- Norepinephrine infusion rate(fifth hour)