Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Delirium
研究概览
简要总结
Purpose of the Study Critical illness requiring life support affects over 150 000 people in Ontario every year. With aggressive support, the number of people who die from critical illness is decreasing. However, people who survive often have neurological problems. These neurological problems often include difficulties with memory, concentration, and attention. These problems are associated with poor quality of life among survivors of critical illness. The aim of this study is to identify the factors that contribute to these neurological deficits. Specifically, the investigators are testing whether changes in oxygen delivery to the brain during critical illness are related to both short- and long-term neurological complications.
Procedures involved in the Research When patients are diagnosed with a critical illness such as shock or respiratory failure, they are treated with intravenous fluids, medications to raise their blood pressure, and can be placed on a ventilator to assist with their breathing. They are observed in an intensive care unit (ICU). This research protocol does NOT interfere with the normal treatment of patients with critical illness. The procedure involved in this research protocol requires the placement of two stickers to either side of the patient's forehead, and information about oxygen delivery to the brain will be recorded. When the patient has recovered from the critical illness, they will be asked to perform several neurological tests. Some of these tests will be done with a pencil and paper, while others will use a robotic device to test arm movements, reaction time, and concentration.
Potential Harms, Risks or Discomforts:
This research study involves the placement of a sticker sensor to either side of the forehead. Rarely, patients may develop a rash to these electrodes. The investigators monitor patients very carefully for rashes, and if a rash is to occur, the sticker sensor will be removed. With regards to the neurological testing, rarely patients can have some mild muscle stiffness after moving their arms in the robot. The investigators do not expect any other further harms, risks, or discomforts.
详细描述
A detailed protocol is currently under review for funding at Physician Services Incorporated, and can be included pending decision.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Critically ill patients defined as having either:
- •Respiratory failure: Defined as invasive mechanical ventilation for a predicted duration of >24 hours, or:
- •Shock: Defined as being on one of the following agents:
- •norepinephrine (>5 mcg/min) IV
- •epinephrine (at any dose)
- •vasopressin (in combination with another pressor)
- •milrinone (in combination with another pressor)
排除标准
- •expected survival <24 hours
- •history of cognitive dysfunction
- •unable to participate in follow up testing
结局指标
主要结局
Delirium
时间窗: Proportion of ICU stay spent delirious. The average ICU stay is 7 days at our institution, however, some patients may stay much longer. We will perform delirium screening to a maximum of 30 days after ICU admission.
The CAM-ICU and ICDSC are used to screen for delirium in critically ill patients. On the basis of these two validated screening tools, patients will be categorized as either comatose, delirious, or intact. The percentage of ICU stay that the participant spends delirious is the primary outcome measure.
次要结局
- Neurocognitive performance on the RBANS(3 and 12 months)
- Neurocognitive performance on KINARM tasks(3 and 12 months)
- Correlation between brain tissue oxygenation and physiological parameters(First 24 hours of admission)
研究者
Dr. Gordon Boyd
Assistant Professor
Queen's University