"Implementation of a Cognitive Training Program in the Elderly to Reduce the Risk of Postoperative Cognitive Dysfunction in Elective Non-cardiac Surgery "
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- Measure the effectiveness of a cognitive training program on the post op cognitive dysfunction
研究概览
简要总结
Background: The postoperative cognitive dysfunction (POCD) is a frequent complication, often underestimated and leads to a negative impact on the quality of life for patients and their families.
Objective: Measure the effectiveness of the cognitive training in reducing POCD in patients 55 and 70 years old undergoing elective non cardiac surgery with a degree II-III (medium-high) in "Centro Médico Teknon" Barcelona, during 2017-2018.
Methodology: Randomized control clinical trial. The anticipate sample size is approximately 225, 75 in each group. Cognitive training performed at different stages of the perioperative period. Measure the cognitive function through a battery of neuropsychological tests during the preoperative (10 days pre-surgery) and postoperative (at 3 - 30 and 90 days post-surgery). Data analysis: SPSS 22, descriptive and inferential analysis: Chi-square, Student's t-test, ANOVA and Pearson correlation (p<0,05).
Limitations: Loss for non-intervention and loss of follow-up. Applicability: Strategy to improve the quality of life patients and reduce socioeconomic costs associated.
详细描述
Postoperative Cognitive Dysfunction (PCD) is a frequent and serious complication associated with the surgical / anesthetic act. It is an under-recognized and underestimated entity, as it can often go unnoticed even though its effects can be devastating. The cognitive domains affected are diverse and can include memory, perception, verbal abilities and executive functions.
It is not the only postoperative cognitive disorder and for this reason it is important not to confuse it with delirium and dementia. Cognitive dysfunction still does not have a diagnostic code formally defined by ICD-10 (International Classification of Disease) or by the DSM-V, although the medical field has begun to use this term for the general description of those patients who complain about memory alterations and the thought process in the postoperative period. Its detection and evaluation depend on the comparative analysis of the cognitive function (analyzed by means of neuropsychological tests) betinestigatorsen the pre and postoperative period. It is considered, in most of the cases, a mild or moderate cognitive impairment of a transient and reversible nature. Its etiology is unknown, and it is related to a complex and multifactorial pathophysiology. The most accepted physiopathological hypothesis is the inflammatory alteration of the Central nervous system (neuroinflammation) due to surgical trauma, with the consequent deterioration of the cognitive reserve contributing to a cognitive deficit. At the present moment there is no effective strategy tested to prevent PCD.
Some of the most relevant studies on this disorder inestigatorsre published in The Lancet in 1998 (Moller et al.) and Anesthesiology in 2008 (Monk et al.). These studies determined that surgery and anesthesia caused PCD in the long term. They also concluded that the PCD appears in all ages but that old age exponentially increases the risk of suffering it. In addition, a low educational level increases the risk of PCD and people who maintain a PCD after 3 months, are more likely to experience dementia and a higher mortality risk in the first year after surgery.
The relevant impact of this disorder is dependent on an increase in mortality, a workforce loss due to incapacity and early retirement, and social cost due to sick leave, medical and nursing homes for the, now dependent, patient.
At present, it is important to identify, create and evaluate procedures aimed at helping patients at risk from this disorder from anesthesia consultations, as a way to help improve the outcomes. In this sense, this project proposes the validation of cognitive training as a non-pharmacological intervention to reduce incidence and intensity of Postoperative Cognitive Dysfunction.
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
- 55 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>55y <70y
- •Patients ASA I, II, II
- •Medium or high surgical complexity
排除标准
- •previous surgery less than 6 month ago
- •psychiatric disease
- •Neurological disease
- •Brain tumors
- •expected survival less than 3 month
- •emergencies
结局指标
主要结局
Measure the effectiveness of a cognitive training program on the post op cognitive dysfunction
时间窗: 3 months
Impact of a training program on the cognitive dysfunction measured with: Mini-cog test for. Scale: 0-5, normal values \> 3; measurements at 3 days, 1 month and 3 month after surgery
次要结局
- Impact of a training program on the alteration of the daily memory(3 month)
- Impact of a training program on the alterations of anxiety and depression(3 month)
- Measure the development of PCD in relation of anesthesia technique in the diferent patient group(3 month)
- Measure the development of PCD in the different patient groups in relation of age(3 month)
- Measure the development of PCD in relation of duration of surgery in the different patient groups(3 month)
- Measure the development of PCD in relation of type of post operative complications, in the different patient gruops(3 month)
- Impact of a training program on the memory alterations(3month)
- Measure the development of PCD in relation of sex in the different patient groups(3 month)
- Adherence to the cognitive training program(3 month)
研究者
Bibiana Ros Nebot
MSN, RN Anesthesia Nurse
Centro Medico Teknon
