Cognitive Trajectories After Surgery, a Clinical, Observational Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Changes in postoperative cognitive function, part 3
研究概览
简要总结
Research problem and specific questions: Approximately 2.8 million surgeries are conducted yearly in Sweden and of these almost 50% are persons ≥ 60 years. Postoperative cognitive recovery is a concern for older persons. To date, there is no evidence for treating postoperative neurocognitive decline (POCD) and no assessment of cognitive function is routinely performed. The purpose is to is to test digital monitoring in clinical practice: I) test recruitment process and measure attrition rate; II) estimate the difference in main clinical outcomes (POCD) that will inform sample size calculations for the longitudinal observational mixed methods study, III) determine the usability and feasibility of digital monitoring. Participants: 50 patients ≥60 years undergoing inpatient surgery. Outcomes: depression, frailty, cognitive function, postoperative recovery and functional status .
详细描述
The aim is to evaluate the digital cognitive monitoring (Mindmore-P) in clinical practice by:
I) Test recruitment process and measure attrition rate. II) To establish whether it is possible to detect early signs of neurocognitive decline, using a digital postoperative cognitive screening tool i.e. Mindmore-P.
III) To investigate if there are any associations between choice of anesthetic drugs, delirium, duration of anesthesia, preoperative frailty, depression symptoms, postoperative delirium, physical function, and early postoperative recovery.
IV) Determine the usability and feasibility of Mindmore-P. V) Determine patients' experiences of early cognitive recovery in relation to signs of cognitive decline or no signs measured bythe four tests included in Mindmore-P
METHODS AND ANALYSIS Study design This is an observational feasibility study.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>60 years of age undergoing elective non-cardiac surgery with general anesthesia.
- •Duration of surgery >60 minutes
- •Mini-mental state examination score >24.
排除标准
- •Mini-mental state examination, cut-off score of <23 indicating cognitive impairment
- •Unable to read and speak Swedish
- •Uncorrected severe visual or auditory disorder,
- •Disease of the central nervous system
- •Psychiatric diseases
- •Alcoholism or drug dependence
- •Current motor impairment in dominant hand
- •Colour-blindness.
结局指标
主要结局
Changes in postoperative cognitive function, part 3
时间窗: Before surgery and day 1 or 2, and 3 weeks after surgery
Stroop Colour-Word Test (SCW). 24 words spelling out a the name of a colour which is printed in contrasting ink colours (e.g., the word "green" printed with red ink), and the participant is asked to tell the printed colour of the word rather than the word rather than the actual meaning of the word.
Changes in postoperative cognitive function, part 2
时间窗: Before surgery and day 1 or 2, and 3 weeks after surgery
Trail Making Test (TMT- A \& B), consisting of of 25 circles with letters or numbers on the screen. 4. Symbol Digits Processing Test (SDPT).The test consist of nine symbol-digit pairings at the top of the screen, one symbol in the middle of the screen, and a number grid at the bottom of the screen.
Changes in postoperative cognitive function, part 4
时间窗: Before surgery and day 1 or 2, and 3 weeks after surgery
Symbol Digits Processing Test (SDPT).The test consist of nine symbol-digit pairings at the top of the screen, one symbol in the middle of the screen, and a number grid at the bottom of the screen.
Recruitment process and attrition rate
时间窗: Through study completion, an average of 8 months
Number of possible participants vs. number of participants who accept to participate and number of participants who complete the study
Changes in postoperative cognitive function, part 1
时间窗: Before surgery and day 1 or 2, and 3 weeks after surgery
Consortium to Establish a Registry for Alzheimer´s Disease (CERAD) A 10-word verbal learning test with 3 learning trials, a recall trial after \~7 min.
次要结局
- Frailty(Before surgery)
- Signs of and changes in depression(Before surgery and 3 weeks after surgery)
- Changes in functional capacity(Before surgery and 3 weeks after surgery)
- Changes in postoperative recovery(Before surgery and day 1 or 2, and 3 weeks after surgery)
- Usability of Mindmore-P(3 weeks after surgery)
- Feasibility and patients' experiences of early postoperative cognitive recovery(One month after surgery)
- Signs of and changes in postoperative delirium(After surgery twice a day on postoperative day 1-2)
研究者
Ulrica Nilsson
Professor
Karolinska Institutet