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临床试验/NCT01539382
NCT01539382已完成不适用

Optimizing Cerebral Oxygenation in Cardiac Surgery

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
1
主要终点
Postoperative neurocognitive decline

研究概览

简要总结

The purpose of this study is to test whether keeping the amount of oxygen delivered to the brain above a certain level during surgery and 24-hours after surgery improves recovery.

Hypothesis 1: keeping the amount of oxygen delivered to the brain above a certain level during surgery and 24-hours after surgery improves cognitive and neurological outcomes after cardiac and aortic surgery.

Hypothesis 2: keeping the amount of oxygen delivered to the brain above a certain level during surgery and 24-hours after surgery helps reduce major organ problems after cardiac and aortic surgery.

To test our hypotheses, the investigators will conduct a randomized control trial. Patients will be randomly assigned to one of two possible study groups. In the Treatment Group, the brain oxygen level will be watched by doctors and used to guide care in the operating room and the first day in the intensive care unit after surgery. Doctors will try to keep the brain oxygen level in a normal range by adjusting your blood pressure, carbon dioxide and blood acidity levels, and blood count. In the Control Group, the doctors will not be aware of the brain oxygen level unless it falls below a level that may be dangerous. If a patient's brain oxygen falls below such a level, the doctors will adjust the blood pressure, carbon dioxide and blood acidity levels, and blood count to increase the brain oxygen level. All other procedures will be part of regular medical care and will be performed according to the standard of care.

详细描述

Background

There is a high incidence of cognitive dysfunction, neurological dysfunction, and multi-system organ dysfunction syndrome following cardiac surgery. There is preliminary evidence that optimization of cerebral oxygenation is associated with improved neurological and clinical outcomes.

Cerebral oximetry using near infrared spectroscopy (NIRS) is based on the ability of near-infrared light to penetrate scalp and skull, and its differential intracranial absorbance by oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb). Cerebral oximetry measures regional cerebral tissue oxygen saturation (SctO2) at the microvascular level (arterioles, venules, and capillaries) and provides information on the availability of oxygen in brain tissue. Unlike digital pulse oximetry, SctO2 reflects regional cerebral metabolism and the regional balance of cerebral oxygen supply and demand. NIRS SctO2 is the most promising monitoring technology for the purpose of guiding interventions targeted to improve brain and other organ preservation. The reasons for this include: (1) SctO2 is continuous, non-invasive, and available at the point of care; and (2) SctO2 is a sensitive index of cerebral hypoxia and/or cerebral ischemia, which are the main causes of brain injury in clinical settings. The preliminary work of Murkin strongly suggests that optimizing tissue perfusion using protocol-based treatments that optimize SctO2 decrease end-organ dysfunction in cardiothoracic surgical patients.

Recruitment Methods

Potential subjects are patients who are planned to undergo elective cardiac surgery at Mount Sinai Hospital. Potential subjects will be identified by checking the pre-admission schedule f or cardiothoracic surgery on a daily basis. Patients will be recruited at the surgical pre-admission screening; written informed consent will be obtained.

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)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients scheduled to undergo elective cardiac or thoracic aortic surgery requiring cardiopulmonary bypass

排除标准

  • Severe preoperative cognitive impairment (i.e., dementia or developmental intellectual disability)
  • Sensory or motor impairment that would preclude reliable operation of a computer and keyboard
  • Lack of access to use computer-based cognitive evaluation
  • Non-English speaking patients
  • Renal failure requiring dialysis
  • Respiratory failure requiring home oxygen use
  • Child's B or C hepatic failure

结局指标

主要结局

Postoperative neurocognitive decline

时间窗: 6 months after surgery

Postoperative cognitive deficit as defined as negative changes in Z-score of greater than or equal to 1.0 in any of the four neurocognitive domains tested by neurocognitive assessment (Response Speed, Processing Speed, Attention, and Memory).

次要结局

  • Multiple organ dysfunction(During the hospitalization for postoperative recovery, average 8 days)
  • Neurological dysfunction(During the hospitalization for postoperative recovery, average 8 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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