Prediction of Post-operative Cognitive Decline Following Shoulder Surgery in the Beach Chair Position: The Value of Cerebral Oximetry
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
Study Overview
Brief Summary
Surgery to the shoulder may be performed with patients seated upright in a position known as the "Beach Chair Position (BCP)." This position has certain advantages compared to alternative surgical positions (e.g. side lying) in some situations. However, it has been found that surgery in the BCP can temporarily decrease the amount of oxygen in the brain as a result of the combined effects of gravity and anaesthesia. This can result in complications following surgery such as some memory loss and confusion. Rarely, more serious complications have been reported in the past including death and stroke.
Due to these reported complications the use of "cerebral oximetry" during shoulder surgery in the BCP has become more common. Before and during surgery, a monitor placed on the patients forehead measures the amount of oxygen present in the brain to help control this to an acceptable level. A number of monitors are now commercially available. Two monitors are commonly discussed in the literature; the INVOS™ 5100 and the FORE-SIGHT® machines. However, the actual relationship between the supply of oxygen to the brain during surgery and the chance of later developing problems with memory and thinking (known as "post operative cognitive decline" - POCD) is not clear. It is also not known if one monitor is more accurate than another at predicting these complications.
Therefore, the main aim of this study is to examine the relationship between cerebral oxygen levels during shoulder surgery and the incidence of POCD (i.e. problems with memory and thinking). A second aim is to compare the INVOS™ 5100 and FORE-SIGHT® monitors ability to measure cerebral oxygen and cerebral desaturation events (CDEs) as well as the importance of other key clinical variables (e.g. blood pressure, nausea, body fat etc).
Detailed Description
PURPOSE OF THE INVESTIGATION The purpose of this investigation is to generate evidence about cerebral oxygenation during shoulder surgery and the incidence of POCD. Currently, evidence relating to POCD following surgery is conflicting and relates mostly to outcomes following cardiac surgery. There is a strong need to explore this relationship in the specific context of shoulder surgery in the BCP.
INTERVENTION GROUPS This study will involve a single prospective cohort. Patients who meet the selection criteria will be recruited to the study following voluntary informed consent . Cerebral oxygenation will be measured by application of cerebral oximeters to each patients forehead.
AIM OF THE STUDY This study has three aims; (i) To examine the relationship between cerebral desaturation during shoulder surgery in the BCP, and the incidence of POCD.
(ii) To determine the variation in cerebral oxygenation recorded using randomised (for superior/inferior) simultaneous application of the INVOS™ and FORE-SIGHT® oximeters, during shoulder surgery in the beach chair position.
(iii) Assess the relationships between cerebral oxygen desaturation during shoulder surgery in the BCP and variables including mean arterial pressure, incidence of nausea/vomiting, duration of hospital stay, BMI, hypertension and adverse events.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Receiving treatment primarily by, but not restricted to, one of the Primary investigators for a shoulder condition that requires surgery in the BCP.
- •Over 18 years of age
- •Able to read and speak English
Exclusion Criteria
- •Under 18 years of age
- •Pregnant women
- •Pre-operative Mini-Mental State Examination (MMSE) < 24
- •Pre-existing cerebrovascular disease as reported by the assessing medical consultant and recorded in patient charts
- •Orthostatic hypotension
- •American Society of Anaesthesiologists (ASA) physical status III, IV and V*
- •History of drug and/or alcohol abuse
- •Neurological disease (e.g. previous stroke)
- •Significant mood and anxiety disorders as determined by treating consultant.
- •Any other condition, which in the opinion of the investigators, would render the patient unsuitable for participation in the study
Arms & Interventions
Surgery patients
Patients receiving shoulder surgery in the Beach Chair Position, and monitored by both INVOS and FORE-SIGHT monitors.
Intervention: Dual-monitoring (Device)
Outcomes
Primary Outcomes
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
Time Frame: 3 months post-operative
The examinee is verbally presented with a combination of numbers and letters or increasing amounts. The examinee is required to recall the numbers in ascending order then letters in alphabetical order.
Single letter verbal fluency
Time Frame: 3 months post-operative
This task requires the individual to spontaneously generate a list of words in 60 seconds, where the words cannot be name of places, people or other proper nouns.
Rey Auditory Verbal Learning Test
Time Frame: 3 months post-operative
The RAVLT assesses immediate and delayed auditory memory recall and recognition. The task consists of 15 nouns learned over 5 trials with a free recall after each presentation. The order of presentation remaining fixed across trials (List A). At the end of the 5th trial an interference list of 15 words is presented (List B), following a free recall of that list. Immediately after this, delayed recall of the first list is tested. Following a 20-minute delay, delayed recall and recognition of the first word list is assessed.
Trail making test: Delis-Kaplan Executive Function System
Time Frame: 3 months post-operative
The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
Trail making test: Delis-Kaplan Executive Function System
Time Frame: Baseline
The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
Trail making test: Delis-Kaplan Executive Function System
Time Frame: 1 day post-operative
The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
Trail making test: Delis-Kaplan Executive Function System
Time Frame: 8-14 days post-operative
The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
Trail making test: Delis-Kaplan Executive Function System
Time Frame: 6 weeks post-operative
The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
Single letter verbal fluency
Time Frame: Baseline
This task requires the individual to spontaneously generate a list of words in 60 seconds, where the words cannot be name of places, people or other proper nouns.
Single letter verbal fluency
Time Frame: 1 day post-operative
This task requires the individual to spontaneously generate a list of words in 60 seconds, where the words cannot be name of places, people or other proper nouns.
Single letter verbal fluency
Time Frame: 8-14 days post-operative
This task requires the individual to spontaneously generate a list of words in 60 seconds, where the words cannot be name of places, people or other proper nouns.
Single letter verbal fluency
Time Frame: 6 weeks post-operative
This task requires the individual to spontaneously generate a list of words in 60 seconds, where the words cannot be name of places, people or other proper nouns.
Rey Auditory Verbal Learning Test
Time Frame: Baseline
The RAVLT assesses immediate and delayed auditory memory recall and recognition. The task consists of 15 nouns learned over 5 trials with a free recall after each presentation. The order of presentation remaining fixed across trials (List A). At the end of the 5th trial an interference list of 15 words is presented (List B), following a free recall of that list. Immediately after this, delayed recall of the first list is tested. Following a 20-minute delay, delayed recall and recognition of the first word list is assessed.
Rey Auditory Verbal Learning Test
Time Frame: 1 day post-operative
The RAVLT assesses immediate and delayed auditory memory recall and recognition. The task consists of 15 nouns learned over 5 trials with a free recall after each presentation. The order of presentation remaining fixed across trials (List A). At the end of the 5th trial an interference list of 15 words is presented (List B), following a free recall of that list. Immediately after this, delayed recall of the first list is tested. Following a 20-minute delay, delayed recall and recognition of the first word list is assessed.
Rey Auditory Verbal Learning Test
Time Frame: 8-14 days post-operative
The RAVLT assesses immediate and delayed auditory memory recall and recognition. The task consists of 15 nouns learned over 5 trials with a free recall after each presentation. The order of presentation remaining fixed across trials (List A). At the end of the 5th trial an interference list of 15 words is presented (List B), following a free recall of that list. Immediately after this, delayed recall of the first list is tested. Following a 20-minute delay, delayed recall and recognition of the first word list is assessed.
Rey Auditory Verbal Learning Test
Time Frame: 6 weeks post-operative
The RAVLT assesses immediate and delayed auditory memory recall and recognition. The task consists of 15 nouns learned over 5 trials with a free recall after each presentation. The order of presentation remaining fixed across trials (List A). At the end of the 5th trial an interference list of 15 words is presented (List B), following a free recall of that list. Immediately after this, delayed recall of the first list is tested. Following a 20-minute delay, delayed recall and recognition of the first word list is assessed.
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
Time Frame: Baseline
The examinee is verbally presented with a combination of numbers and letters or increasing amounts. The examinee is required to recall the numbers in ascending order then letters in alphabetical order.
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
Time Frame: 1 day post-operative
The examinee is verbally presented with a combination of numbers and letters or increasing amounts. The examinee is required to recall the numbers in ascending order then letters in alphabetical order.
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
Time Frame: 8-14 days post-operative
The examinee is verbally presented with a combination of numbers and letters or increasing amounts. The examinee is required to recall the numbers in ascending order then letters in alphabetical order.
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
Time Frame: 6 weeks post-operative
The examinee is verbally presented with a combination of numbers and letters or increasing amounts. The examinee is required to recall the numbers in ascending order then letters in alphabetical order.
Secondary Outcomes
- Cerebral desaturation events (INVOS)(Intra-operative)
- Hypertension(Baseline)
- Duration of hospital stay(8-14 days)
- Adverse events(3 months)
- Mean arterial pressure(Intra-operative)
- Cerebral desaturation events (FORE-SIGHT)(Intra-operative)
- Body Mass Index(Baseline)
- Nausea and vomiting within 48 hours(1 day, 8-14 days)
- Adverse events(Intra-operative)
- Adverse events(1 day)
- Adverse events(8-14 days)
- Adverse events(6 weeks)