Impact of Neurochecks on Sleep in Critically Ill Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Sleep efficiency
研究概览
简要总结
Background: Following acute brain injury (ABI), patients are monitored in the intensive care unit (ICU) where providers rely on frequent neurological examinations ("neurochecks") to assess for neurodeterioration. Serial neurochecks are part of guideline recommendations, but there is equipoise between hourly (Q1) and every-other-hour (Q2) evaluation. In the ICU, care-related awakenings occur frequently, but it is unclear if differential neurocheck frequencies result in differential sleep, providing the scientific premise for this proposal.
Population: Thirty patients (N=15 per group) who have undergone elective aneurysm coiling will be enrolled. On post-operative day (POD) 0, patients will be screened and approached for informed consent if they do not meet exclusion criteria, e.g., prior intracranial injury, sleep disorders, cognitive impairment, mechanical ventilation. Patients with elective aneurysm coiling are being chosen because they require ICU level of care following their intracranial procedure, but do not have structural brain injury or ongoing sedation needs that might impact sleep measurements.
Methods: Usual care: Patients are monitored every 15-30 minutes for up to 6 hours post-procedure, then Q1 or Q2 for up to 24 hours. If these patients remain stable, they are discharged home on post-operative day (POD) 1. Proposed Intervention: Enrolled patients will be randomized to Q1 or Q2 neurochecks following the institutionally required 6 hours of stable neurological and vascular checks. Once randomized, patients will undergo placement of electroencephalogram (EEG) with video, electrooculogram, and chin lead. The video EEG will be in place for at least 8 hours to include the overnight (10PM-6AM) time period. Following completion of the recording, the signals obtained will be reviewed by a blinded polysomnographic sleep technician for sleep characteristics including quantitative assessments of wakefulness, deep (N3) sleep, REM sleep, sleep efficiency, and sleep fragmentation and arousals. On POD1, patients and their nurse will fill out the Richards-Campbell Sleep Questionnaire to rate subjective sleep quality.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a. Adult patients who are status post uncomplicated elective coiling of unruptured cerebral aneurysm.
排除标准
- •Patients with past or current intracranial injury or disease.
- •Patients with known flow-limiting pathology of carotid arteries, vertebral arteries, or intracranial arteries.
- •Incomplete resolution of aneurysm.
- •Known sleep disorders (e.g., insomnia)
- •Incarceration.
- •Inability to communicate in English
- •Cognitive impairment or lack of decision-making capacity.
- •Ongoing sedation.
- •Mechanical ventilation
研究组 & 干预措施
Hourly Neurochecks
Patients awakened for neurological exams every hour
干预措施: Neurocheck frequency (Behavioral)
Every-Other-Hour Neurochecks
Patients awakened for neurological exams every-other-hour
干预措施: Neurocheck frequency (Behavioral)
结局指标
主要结局
Sleep efficiency
时间窗: Within 24 hours of enrollment
Ratio of total sleep time compared to time in bed, reported as a percentage
次要结局
- Deep Sleep(Within 24 hour of enrollment)
- Arousals(Within 24 hour of enrollment)
- Sleep quality (subjective)(Within 24 hour of enrollment)
- Wakefulness(Within 24 hour of enrollment)
- REM Sleep(Within 24 hour of enrollment)
研究者
Jamie Labuzetta
Clinical Professor of Neurosciences
University of California, San Diego