跳至主要内容
临床试验/NCT03293550
NCT03293550已完成不适用

The Association Between Minor Brain Injuries and Level of Anesthesia Detected by a New EEG Based Tool, to Delirium and Post-operative Cognitive Dysfunction After Cardiac and Non-cardiac Surgery - a Proof of Concept Study

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2017年12月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
1
主要终点
Correlation of intra operative EEG changes to late post operative cognitive dysfunction

研究概览

简要总结

As the population ages and medical progress is made, many elderly patients that previously would not have been candidates for surgery are now undergoing operations. In this group of older patients, brain dysfunction after anesthesia and surgery is well recognized and categorized into two distinct clinical entities; Post-operative cognitive delirium (POD) and post-operative cognitive dysfunction (POCD).

Delirium is an acute and fluctuating deterioration in attention accompanied by either a change in cognition or arousal and is often diagnosed by criteria established in the Confusion Assessment Method (CAM). Delirium can present as hypoactive (decreased alertness, motor activity and anhedonia), as hyperactive (agitated and combative) or as mixed forms. Age and the type of operation are the major risk factors.

Post-operative cognitive dysfunction (POCD) is a term used to describe subtle changes in cognition, such as memory and executive function. The most commonly seen problems are memory impairment and impaired performance on intellectual tasks. In severe cases, it can lead to inability to perform daily living functions. It was previously found that the presence of cognitive dysfunction 3 months after non-cardiac surgery was associated with an increased mortality. The mechanisms leading to cognitive impairment after anesthesia and surgery are not yet fully clear. The risk factors are related to patient characteristics, type of operation and anesthetic management.

Despite its limitations over-anesthesia as monitored by BIS was at-least correlative with POD. Therefore it is hopeful that an even more precise evaluation of the level of anesthesia will improve POD prediction (and thereby prevention) even further.

On the other hand the measure of depth of anesthesia by itself does not provide sufficient prediction for POCD. In POCD a major role has been assigned to hippocampal damage.

The investigators have recently demonstrated that temporary hippocampal interruptions are manifested by interhemispheric desynchronization, which are recognized by our new algorithm, which monitors electrophysiological markers of attention and of perception.

The investigators have developed a unique algorithm for analyzing EEG based on the concept of monitoring perception and attention and their interhemispheric synchronization.

The aims of this proof of concept study are: (i) to find-out whether interhemispheric desynchronization of attentional processes is associated with POCD; (ii) to find out whether the level of anesthesia, is linked primary to POD and secondary to POCD.

详细描述

As the population ages and medical progress is made, many elderly patients that previously would not have been candidates for surgery are now undergoing operations. In this group of older patients, brain dysfunction after anesthesia and surgery is well recognized and categorized into two distinct clinical entities; Post-operative cognitive delirium (POD) and post-operative cognitive dysfunction (POCD).

Delirium is an acute and fluctuating deterioration in attention accompanied by either a change in cognition or arousal and is often diagnosed by criteria established in the Confusion Assessment Method (CAM). Delirium can present as hypoactive (decreased alertness, motor activity and anhedonia), as hyperactive (agitated and combative) or as mixed forms. Age and the type of operation are the major risk factors.

Post-operative cognitive dysfunction (POCD) is a term used to describe subtle changes in cognition, such as memory and executive function. The most commonly seen problems are memory impairment and impaired performance on intellectual tasks. In severe cases, it can lead to inability to perform daily living functions. The reported incidence figures for postoperative cognitive dysfunction vary depending on the group of patients studied, the definition of POCD used, the tests used to establish the diagnosis and their statistical evaluation, the timing of testing, and the choice of control group. The diagnosis of POCD relies on the use of neuropsychological tests, including; visual verbal learning test, based on Rey's auditive recall of words, the concept shifting test, based on the trail- making test from Halstead and Reitan's neuropsychological test battery, the Stroop color word interference test , the letter-digit coding, based on the symbol-digit substitution task from the Wechsler adult intelligence scale and the four boxes test. In a large prospective multicenter cohort study, it was found that the presence of cognitive dysfunction 3 months after noncardiac surgery was associated with an increased mortality. Furthermore, patients with cognitive decline at 1 week had an increased risk of leaving the labor market prematurely and a higher prevalence of time receiving social transfer payments. The mechanisms leading to cognitive impairment after anesthesia and surgery are not yet fully clear. The risk factors for developing POCD are related to patient characteristics, type of operation and anesthetic management.

Cardiovascular, respiratory, hepatic, and renal insufficiency are all associated with impaired brain performance. It is theoretically obvious that an adequate intraoperative oxygen supply for all vital organs is essential if postoperative cerebral dysfunction is to be avoided. Casai et al found that brain desaturation (rSO2 decrease <75% of baseline) occurred in 40% of elderly patients after noncardiac surgery, and the cerebral desaturation was linked with a high incidence of POCD. A recent systematic review shows that reductions in cerebral oxygen saturation (rSO2) during cardiac surgery may indicate CPB cannula malposition, particularly during aortic surgery. However, only weak evidence links low rSO2 during cardiac surgery to POCD.

POCD is a well-recognized clinical phenomenon of multifactorial origin; emboli, hypoperfusion, inflammation, and patient's preoperative cerebral dysfunction Meticulous surgical and anesthesiological techniques are important for preventing complications and keeping the risk of POCD to a minimum.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 65 years or older undergoing elective cardiac surgery (CABG or valve replacement) or hip/knee replacement.

排除标准

  • any of the following criteria;
  • inability or refusal to provide informed consent,
  • significant visual impairment so that the pictures of the confusion assessment method could not be interpreted to accurately test to assess delirium,
  • profound dementia or aphasia that interfered with the assessment of delirium,
  • inability to speak Hebrew/ Russian or Arabic so that a language barrier was not confused with postoperative confusion.
  • Any previously documented major neurologic or psychiatric dysfunction

结局指标

主要结局

Correlation of intra operative EEG changes to late post operative cognitive dysfunction

时间窗: The diagnosis of cognitive dysfunction is assessed post operative on day 90 and is compared to baseline pre surgery cognitive function.

Correlation of EEG changes as measured by a new EEG based algorithm to post operative cognitive dysfunction

Correlation of intra operative EEG changes to early post operative cognitive dysfunction

时间窗: The diagnosis of cognitive dysfunction is assessed post operative on day 7 and compared to baseline pre surgery cognitive function.

Correlation of EEG changes as measured by a new EEG based algorithm to post operative cognitive dysfunction

Correlation of intra operative EEG changes to 45 days post operative cognitive dysfunction

时间窗: The diagnosis of cognitive dysfunction is assessed post operative on day 45 and is compared to baseline pre surgery cognitive function.

Correlation of EEG changes as measured by a new EEG based algorithm to post operative cognitive dysfunction

Correlation of depth of anesthesia to post operative delirium

时间窗: The diagnosis of delirium is assessed two hours after the operation, when the patient is fully awake, in the post anesthesia care unit (PACU)

Correlation of depth of anesthesia, as measured by a new EEG based algorithm, to post operative delirium

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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