Centre For Neuroscience Studies, Queen's University, Kingston, Ontario, Canada.
School of Medicine, Queen's University, Kingston, Ontario, Canada.
BMJ Open. 2019 Jun 25;9(6):e029189. doi: 10.1136/bmjopen-2019-029189.
Survivors of critical illness frequently exhibit acute and chronic neurological complications. The underlying aetiology of this dysfunction remains unknown but may be associated with cerebral ischaemia. This study will use near-infrared spectroscopy to non-invasively quantify regional cerebral oxygenation (rSO) to assess the association between poor rSO during the first 72 hours of critical illness with delirium severity, as well as long-term sensorimotor and cognitive impairment among intensive care unit (ICU) survivors. Further, the physiological determinants of rSO will be examined.
This multicentre prospective observational study will consider adult patients (≥18 years old) eligible for enrolment if within 24 hours of ICU admission, they require mechanical ventilation and/or vasopressor support. For 72 hours, rSO will be continuously recorded, while vital signs (eg, heart rate) and peripheral oxygenation saturation will be concurrently captured with data monitoring software. Arterial and central venous gases will be sampled every 12 hours for the 72 hours recording period and will include: pH, PaO2, PaCO2, and haemoglobin concentration. Participants will be screened daily for delirium with the confusion assessment method (CAM)-ICU, whereas the brief-CAM will be used on the ward. At 3 and 12 months post-ICU discharge, neurological function will be assessed with the Repeatable Battery for the Assessment of Neuropsychological Status and KINARM sensorimotor and cognitive robot-based behavioural tasks.
The study protocol has been approved in Ontario by a central research ethics board (Clinical Trials Ontario); non-Ontario sites will obtain local ethics approval. The study will be conducted under the guidance of the Canadian Critical Care Trials Group (CCCTG) and the results of this study will be presented at national meetings of the CCCTG for internal peer review. Results will also be presented at national/international scientific conferences. On completion, the study findings will be submitted for publication in peer-reviewed journals.
NCT03141619.
危重病幸存者常出现急性和慢性神经并发症。这种功能障碍的潜在病因尚不清楚，但可能与脑缺血有关。本研究将使用近红外光谱技术无创性地量化局部脑氧合（rSO），以评估危重病最初 72 小时内 rSO 较差与谵妄严重程度之间的关系，以及 ICU 幸存者的长期感觉运动和认知障碍。此外，还将检查 rSO 的生理决定因素。
这项多中心前瞻性观察研究将考虑符合以下条件的成年患者（≥18 岁）入选：如果在 ICU 入院后 24 小时内，患者需要机械通气和/或血管加压支持。在 72 小时内，将连续记录 rSO，同时使用数据监测软件同时捕获生命体征（如心率）和外周血氧饱和度。在 72 小时记录期间，将每 12 小时采集一次动脉和中心静脉血气样本，并包括 pH、PaO2、PaCO2 和血红蛋白浓度。每天用 ICU 意识模糊评估法（CAM）筛查患者是否发生谵妄，而在病房中使用简易 CAM。在 ICU 出院后 3 个月和 12 个月时，使用重复性成套神经心理状态评估量表（RBANS）和 KINARM 感觉运动和认知机器人行为任务评估神经功能。
该研究方案已在安大略省由一个中央研究伦理委员会（临床试验安大略省）批准；非安大略省的地点将获得当地伦理批准。该研究将在加拿大危重病试验组（CCCTG）的指导下进行，研究结果将在 CCCTG 的全国会议上进行内部同行评审。结果也将在全国/国际科学会议上展示。研究完成后，研究结果将提交给同行评议期刊发表。
NCT03141619。
