Postoperative Delirium
Conditions
Keywords
older patients, frailty, neurocognitive disorder, cognitive stimulation, anaesthesia
Brief summary
The aim of this clinical trial is to test whether daily postoperative cognitive training can prevent delirium in older patients after major surgery. The main questions to be answered is: Can daily cognitive training reduce the rate of postoperative delirium in older patients after surgery? Participants will be visited daily for the first 5 days after surgery and asked to take part in a tablet-based cognitive training programme for 2 hours a day (in 2 sessions). The researchers will compare patients who receive the training with a control group of patients who listen to audio books for the same amount of time and a control group who receive standard care (no intervention).
Detailed description
The most common postoperative complication in aged patients is postoperative delirium (POD), which often progresses to permanent postoperative neurocognitive disorder (pNCD). POD and pNCD are associated with significantly increased postoperative morbidity and mortality. Prevention of POD is therefore a primary therapeutic goal in the care of elderly patients. The aim of this project is to investigate the effect of cognitive stimulation on the occurrence of POD in older patients at risk after surgery. Patients undergoing surgery who are at least 70 years old and have an increased risk of postoperative delirium will be included. The increased risk will be assessed in a preoperative assessment as part of the anaesthetic premedication consultation. It is defined as the presence of frailty (Clinical Frailty Scale, CFS and Longitudinal Urban Cohort Study Age Function Index, LUCAS-FI), cognitive impairment (Montreal Cognition Assessment Test, MoCA) or increased morbidity (Hall Risk Analysis Index). The intervention takes the form of computer-based cognitive training in the areas of attention, processing speed, memory, emotional intelligence, reasoning and orientation. Positive effects of this training have already been shown in the treatment of mild cognitive impairment (MCI), dementia and tumour-related cognitive impairment. The training takes place under supervision for 120 minutes a day from the first to the fifth postoperative day. It is hypothesised that postoperative cognitive training can reduce the incidence of delirium in the first five days after surgery. Secondary endpoints are the reduction of neurocognitive dysfunction at one week, six weeks and six months after surgery, maintenance of function and quality of life at six months. In order to adjust for the stimulating effects of interacting with study staff during the study visits, a control group listening to an audio book (also brought and set up by study staff) is included in the trial.
Interventions
BEHAVIORALCognitive training
The intervention consists of computer-based cognitive training in the areas of attention, processing speed, memory, emotional intelligence, reasoning and orientation. The training takes place under supervision for 120 minutes a day from the first to the fifth postoperative day.
BEHAVIORALListen to audio book
Here, an audio book is listened to for 2h daily for the first five postoperative days (or until discharge from hospital if earlier). The audio book is brought and set up by study staff.
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
prospective, randomized-controlled trial
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 70 years or older, * planned surgery (abdominal surgery: general surgery, urology or gynaecology; spinal surgery, vascular medicine, cardiothoracic surgery, major trauma surgery), * increased perioperative risk (frailty, cognitive impairment, multimorbidity).
Exclusion criteria
* Unable to give consent, * severe cognitive disorder or mental retardation (if training cannot be carried out) * Insufficient knowledge of German
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative delirium within the first five days after surgery | delirium screening twice daily from postoperative day 1-5 | Delirium screened twice daily using the 3D-Confusion Assessment Method (3D-CAM) for the first five days after surgery (0-4 hallmarks; hallmark 1+2 and 3+4 = delirium) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative neurocognitive disorder | postoperative day 7 (1 week after surgery) | delayed neurocognitive recovery (compared to baseline), measured by telephone-Montreal Cognitive Assessment (MOCA) (0-15 points; 10 points or less = cognitive impairment) |
| Functional state (patient-reported) | 6 weeks after surgery | compared to baseline, assessed by World Health Organization Disability Assessment (WHODAS) 2.0 questionnaire (36-item, likert scale) |
| Functional state (measured) | 6 weeks after surgery | compared to baseline, assessed by functional independence measure (FIM) (18 items with 0-7 points each, less points = less functionality) |
| Quality of Life (by questionnaire) | 6 weeks after surgery | compared to baseline, assessed by World Health Organization Quality of Life -older adults module (WHOQOL-OLD)-questionnaire (24 item, likert scale) |
| Quality of Life (by visual analogue scale) | 6 weeks after surgery | compared to baseline, assessed by EQ-5D-5L- questionnaire (0-100 points, 100 points = best quality of life) |
Outcome results
None listed