Cerebral Perfusion in the Beach Chair Position
Prediction of Post-operative Cognitive Decline Following Shoulder Surgery in the Beach Chair Position: The Value of Cerebral Oximetry
1 other identifier
interventional
200
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2016
CompletedFirst Posted
Study publicly available on registry
January 30, 2017
CompletedStudy Start
First participant enrolled
May 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJanuary 16, 2019
January 1, 2019
2.5 years
December 29, 2016
January 14, 2019
Conditions
Outcome Measures
Primary Outcomes (20)
Trail making test: Delis-Kaplan Executive Function System
The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
Baseline
Trail making test: Delis-Kaplan Executive Function System
The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
1 day post-operative
Trail making test: Delis-Kaplan Executive Function System
The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
8-14 days post-operative
Trail making test: Delis-Kaplan Executive Function System
The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
6 weeks post-operative
Trail making test: Delis-Kaplan Executive Function System
The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
3 months post-operative
Single letter verbal fluency
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.
Baseline
Single letter verbal fluency
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.
1 day post-operative
Single letter verbal fluency
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.
8-14 days post-operative
Single letter verbal fluency
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.
6 weeks post-operative
Single letter verbal fluency
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.
3 months post-operative
Rey Auditory Verbal Learning Test
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.
Baseline
Rey Auditory Verbal Learning Test
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.
1 day post-operative
Rey Auditory Verbal Learning Test
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.
8-14 days post-operative
Rey Auditory Verbal Learning Test
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.
6 weeks post-operative
Rey Auditory Verbal Learning Test
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.
3 months post-operative
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
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.
Baseline
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
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.
1 day post-operative
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
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.
8-14 days post-operative
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
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.
6 weeks post-operative
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
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.
3 months post-operative
Secondary Outcomes (12)
Cerebral desaturation events (INVOS)
Intra-operative
Cerebral desaturation events (FORE-SIGHT)
Intra-operative
Mean arterial pressure
Intra-operative
Body Mass Index
Baseline
Hypertension
Baseline
- +7 more secondary outcomes
Other Outcomes (3)
Depression Anxiety and Stress Scale-21
Baseline, 1 day, 8-14 days, 6 weeks, 3 months
Social Relationships and Support Scale
Baseline, 1 day, 8-14 days, 6 weeks, 3 months
Loneliness Scale
Baseline, 1 day, 8-14 days, 6 weeks, 3 months
Study Arms (1)
Surgery patients
EXPERIMENTALPatients receiving shoulder surgery in the Beach Chair Position, and monitored by both INVOS and FORE-SIGHT monitors.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brisbane Hand and Upper Limb Research Institutelead
- Medtroniccollaborator
- CAS Medical Systems, Inc.collaborator
Study Sites (1)
Brisbane Hand and Upper Limb Research Institute, Brisbane Private Hospital
Brisbane, Queensland, 4000, Australia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Ross, MBBS
Director
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2016
First Posted
January 30, 2017
Study Start
May 25, 2017
Primary Completion
December 1, 2019
Study Completion
June 1, 2020
Last Updated
January 16, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will share
Deidentified cerebral oximeter data acquisition files will be made available to the equipment manufacturers (Medtronic, CASMED) at the conclusion of the study.