Effects of Feeding Schedule on the Development of ICU Delirium
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Percent of patients developing delirium.
研究概览
简要总结
This study will investigate if enteric feeding schedules alter the development of delirium in Intensive Care Unit patients who have been placed on mechanical ventilation. Delirium is an altered state of consciousness, which can involve agitation, inattention, and decreased awareness. We will enroll Intensive Care Unit patients who have been placed on a ventilator and are being given tube feedings. We will randomize participants into two groups: one group will receive continuous feedings via feeding tube, and the other group will receive feedings on a schedule to mimic breakfast, lunch, a snack, and dinner. Subjects will be assessed for the development of delirium. Subjects will also be monitored for sleep quality.
详细描述
Patients will need to have at least 48 hours of enteric feedings to be included, and will be stratified by their APACHE IV score. Patients will be randomized into time restricted feeding vs continuous feeding by investigators, with no change in caloric intake nor nutrient content from orders. Patients will be assessed for delirium using the CAM-ICU (Confusion Assessment Method in the Intensive Care Unit) screening tool every twelve hours. At the time of the CAM ICU assessment, as part of the experimental design, the patient's sleep will be monitored by X8 Sleep Profiler device, placed and secured to their forehead, and the Sleep Profiler device will collect information regarding sleep quality as assessed by relative delta power, relative theta power and relative beta power.
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 (Participant)
盲法说明
Participants will be under sedation. The outcome assessor for delirium (primary outcome) is not blinded. Assessors rating the sleep quality (secondary outcome) will be blinded.
入排标准
- 年龄范围
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to the ICU
- •Mechanically ventilated
- •Receiving enteric feedings for at least 48 hours
排除标准
- •Pregnancy
- •Previously diagnosed neurocognitive disorders,
- •Alcohol withdrawal and history of alcohol dependence
结局指标
主要结局
Percent of patients developing delirium.
时间窗: 48 hours after admission to the ICU.
The development of delirium as measured by the CAM-ICU (Confusion Assessment Method for the ICU) protocol. The percent of patients developing delirium will be assessed in each arm. Delirium will be assessed every 12 hours.
次要结局
- Change in sleep quality assessed using theta power.(Measurement will be made from study enrollment to extubation, up to 1 week.)
- Change in sleep quality using beta power.(Measurement will be made from study enrollment to extubation, up to 1 week.)
- Change in sleep quality assessed using delta power.(Measurement will be made from study enrollment to extubation, up to 1 week.)
研究者
Deepali Dixit, Pharm.D., BCPS, BCCCP, FCCM
Clinical Associate Professor
Rutgers, The State University of New Jersey