EEG Phase Synchrony, Sedation and Delirium in the CVICU (SOS)
EEG Phase SynchrOny, Sedation and Delirium in the CVICU - The SOS Study
研究概览
详细说明
Aim 1: To quantify EEG phase synchrony changes, both globally and locally by brain region, during emergence from medically induced coma required for performance of a cardiovascular related operation (deep sedation defined as a Riker Sedation-Agitation Scale [SAS] of 1-2).
Hypothesis: The global R-index will be increased above baseline at multiple frequency bandwidths and the magnitude of R-index will correlate with the sedative dosage (as a crude measure of depth). The rate of fluctuations of the R-index will decrease with deeper sedation.
Aim 2: To compare the magnitude of the EEG phase synchrony globally and locally in patients emerging from coma; a patient's pre-anesthesia phase will serve as a control.
Hypothesis: Fluctuations in R-index will vary; fluctuations will be greater in awake adults as compared to while comatose or emerging from coma.
Aim 3: To determine EEG phase synchrony changes in patients with and without delirium during their CVICU stay.
Hypothesis: Lower scores of R-index consistent with increased phase synchrony and lower spatio-temporal variability will be seen while delirious as compared to days when patients are not delirious.
研究类型
注册 (预期的)
联系人和位置
学习地点
-
-
Ontario
-
Toronto、Ontario、加拿大、M5G 2C4
- University Health Network - Toronto General Hospital
-
接触：
- Karolina Walczak, BA
- 电话号码：6639 416-603-5800
- 邮箱：karolina.walczak@uhn.ca
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion criteria:
- Age 30 - 65 years
- Scheduled for first-time CABG or single valve replacement
Exclusion criteria:
- Previous stroke
- Severe pre-existing cognitive impairment (TICS score < 24)
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Electroencephalography (EEG)
大体时间：Until ICU discharge; to a maximum 21 days
|
R-Index -- phase synchrony
|
Until ICU discharge; to a maximum 21 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
CAM-ICU
大体时间：Until ICU discharge; to a maximum 21 days
|
q6 hours while in the ICU: delirium screen instrument
|
Until ICU discharge; to a maximum 21 days
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
EEG的临床试验
-
San Francisco Veterans Affairs Medical Center招聘中
-
San Francisco Veterans Affairs Medical Center招聘中
-
Children's Hospital of PhiladelphiaMasimo Corporation招聘中
-
Baptist Health South FloridaFlorida International University撤销
-
UNEEG Medical A/SZealand University Hospital; Cambridge Cognition Ltd完全的
-
QuantalX Neuroscience完全的中风 | 健康 | 认知障碍 | 失智 | 纤维肌痛 | 认知能力下降 | MCI | 脑外伤 | 多动症 | 产品开发设计 | 创伤后应激障碍 | ABD以色列