Older People's Neurocognitive Recovery After Cardiac Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorKarolinska Institutet
About this trial
Society is aging and advantages in anesthesia and surgery allow more complex interventions in older persons. Old age is a significant risk factor for the development of postoperative neurocognitive decline characterized by a gradual decrease in performance in several cognitive domains such as memory, attention, information processing, and executive functions, leading to problems with performing daily activities and maintaining independence and postoperative complications. The purpose of this study is to measure older persons' postoperative neurocognitive function, to detect neurocognitive decline, and to identify risk factors and difficulties in daily living as well as explore close relatives' experiences of it. We will include 220 participants ≥65 years of age undergoing planned cardiac surgery. Cognitive symptoms and signs and neurocognitive function will be assessed up to 6 months after surgery. Risk/affected factors such as delirium, functional status, recovery, depression, and healthcare-related quality of life, as well as close relative's experiences and burden, will be measured. The results will have immediate relevance for a substantial number of older persons undergoing surgery, and their close relatives, by enhancing knowledge about postoperative cognitive decline and recovery, and subsequently identifying what support needs to be implemented.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for elective or urgent open-heart surgery or minimally invasive cardiac surgery
Resident in the area/region for the current thoracic clinic
Able to read and understand Swedish
Disqualifiers
Physical, mental, and cognitive difficulties that prevent the individual from completing the cognitive tests
Undergone surgery within the last 6 months
Trial population
The study population consists of patients (65 years or older) who have undergone cardiac surgery and their relatives. The study participant is qualified for inclusion if he or she meets all the inclusion criteria and none of the exclusion criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Elective or urgent cardiac surgery
Other interventionThis is a longitudinal observational study to explore postoperative cognitive recovery among older persons (aged 65 or older) undergoing elective or urgent cardiac surgery via sternotomy.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Postoperative cognitive complaints
The Swedish Quality of Recovery cognitive version (SwQoR-Cog) is a self-assessment questionnaire that measures postoperative symptoms. The form consists of 14 statements regarding symptoms and discomforts, of which 11 address cognitive symptoms and 3 are related to pain and nausea. Symptoms and discomforts are rated on an 11-point scale (0=not at all to 10=all the time).
Time frame
Before surgery and weekly up to three months after surgery2
Changes in postoperative cognitive function, part 1
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.
Time frame
Before surgery and 1, 3, and 6 months after surgery3
Changes in postoperative cognitive function, part 2
Trail Making Test (TMT- A \& B) consists of 25 circles with letters or numbers on the screen.
Time frame
Before surgery and 1, 3, and 6 months after surgery4
Changes in postoperative cognitive function, part 3
Stroop Colour-Word Test (SCW). 24 words spelling out 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.
Time frame
Before surgery and 1, 3, and 6 months after surgerySecondary outcomes
1
Postoperative delirium
The Nursing Delirium Scale (Nu-DESC) is an assessment scale where five symptoms are identified and evaluated. A total score of ≥ 2 points indicates the presence of delirium.
Time frame
Twice daily up to postoperative day 72
Perceived self-efficacy
The Swedish General Self-Efficacy Scale (S-GSE) is an instrument that measures perceived self-efficacy in problem-solving and goal achievement. The tool consists of 10 statements that are answered on a 4-point scale, ranging from 1 (not at all true) to 4 (exactly true). This scale is designed to assess an individual's belief in their ability to cope with a variety of difficult demands in life.
Time frame
Before surgery and 1, 3, and 6 months after surgery3
Depressive symtoms
The Patient Health Questionnaire (PHQ-9) is a questionnaire that measures depressive symptoms. The form consists of 9 statements that are answered on a 4-point scale (0=not at all to 3=nearly every day). A total score of ≥ 10 indicates depressive symptoms.
Time frame
Before surgery and 1, 3, and 6 months after surgery4
Functional activity
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS) is a tool that measures the level of functioning. The instrument consists of 12 questions that address difficulties related to health conditions, which are rated on a 5-point scale (1=no difficulty to 5=extreme difficulty/cannot do). A change of ≥5% compared to the baseline measurement indicates a clinically significant difference in the level of functioning.
Time frame
Before surgery and 1, 3, and 6 months after surgeryOther outcomes
1
Demographic and perioperative data
Will be collected from the medical record.
Time frame
At baseline and perioperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Sahlgrenska University Hospital
Collaborator
Source ClinicalTrials.gov