NCT07219069招募中不适用
Bispectral Monitoring on Mechanically Ventilated Patients, a Randomized Clinical Trial. (BIMV Trial)
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Median ventilator time reported in hours
研究概览
简要总结
The purpose of this study is to determine the difference in the duration of mechanical ventilation, to evaluate the difference in ICU length of stay and to determine the difference in the overall dose of sedation medications between the between participants who were monitored using Bispectral index monitoring (BIS) monitors and those who were not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to the medical ICU
- •Intubated on mechanical ventilation
- •On sedation medication infusion
排除标准
- •Patients with a history of chronic opioid use
- •Patients with end-stage liver disease at ICU admission (i.e., International normalized ratio >1.5 and not taking warfarin and/or a total serum bilirubin 1.5 times above normal limits)
- •Pregnant patients
- •Current prisoner
- •Refractory shock: Mean arterial blood pressure below 65 millimeters of mercury(65mmHg) despite maximum doses of 3 pressors. Norepinephrine 70mcg/min; vasopressin 0.03 units/min; epinephrine 35mcg/min; dopamine 20mcg/kg/min and phenylephrine 350mcg/min
- •Inability to complete the required time for follow-up
- •Surgical admission diagnosis
- •Patients with skin conditions precluding BIS monitor sensor adherence
- •Patients on neuromuscular blockade infusion or benzodiazepine infusion
研究组 & 干预措施
BIS group
Experimental
干预措施: BIS group (Device)
Non-BIS group
Active Comparator
干预措施: Non-BIS group (Other)
结局指标
主要结局
Median ventilator time reported in hours
时间窗: from the time the patient was intubated to the time they were extubated, changed to comfort measures, transferred to another facility, or expired(about 4-6 days)
次要结局
- ICU length of stay(During ICU discharge or transfer out of ICU (about 5-7 days after admission to ICU))
- Amount of sedation medication used(From start of ventilation to end of ventilation (about 4-6 days))
研究者
Pascal Kingah
Associate Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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