Cerebral Perfusion in the Beach Chair Position
Primary Purpose
Cognitive Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Dual-monitoring
Sponsored by
About this trial
This is an interventional diagnostic trial for Cognitive Dysfunction
Eligibility Criteria
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
Sites / Locations
- Brisbane Hand and Upper Limb Research Institute, Brisbane Private HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surgery patients
Arm Description
Patients receiving shoulder surgery in the Beach Chair Position, and monitored by both INVOS and FORE-SIGHT monitors.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Cerebral desaturation events (INVOS)
Cerebral desaturation will be defined as a decrease in regional cerebral oxygen saturation greater than, or equal to 20% from baseline or a fall below 50% absolute.
Cerebral desaturation events (FORE-SIGHT)
Cerebral desaturation will be defined as a decrease in regional cerebral oxygen saturation greater than, or equal to 20% from baseline or a fall below 50% absolute.
Mean arterial pressure
Mean arterial blood pressure (mmHg)
Body Mass Index
Patient Body Mass Index (BMI)
Hypertension
Patient-reported hypertension
Nausea and vomiting within 48 hours
Patient-reported nausea and vomiting
Duration of hospital stay
Patient duration of hospital stay
Adverse events
Any adverse events arising during the trial will be closely monitored and followed up until the resolution of symptoms. These will be checked at each assessment stage and recorded on a data collection form.
Adverse events
Any adverse events arising during the trial will be closely monitored and followed up until the resolution of symptoms. These will be checked at each assessment
Adverse events
Any adverse events arising during the trial will be closely monitored and followed up until the resolution of symptoms. These will be checked at each assessment
Adverse events
Any adverse events arising during the trial will be closely monitored and followed up until the resolution of symptoms. These will be checked at each assessment
Adverse events
Any adverse events arising during the trial will be closely monitored and followed up until the resolution of symptoms. These will be checked at each assessment
Full Information
NCT ID
NCT03036345
First Posted
December 29, 2016
Last Updated
January 14, 2019
Sponsor
Brisbane Hand and Upper Limb Research Institute
Collaborators
Medtronic, CAS Medical Systems, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03036345
Brief Title
Cerebral Perfusion in the Beach Chair Position
Official Title
Prediction of Post-operative Cognitive Decline Following Shoulder Surgery in the Beach Chair Position: The Value of Cerebral Oximetry
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 25, 2017 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brisbane Hand and Upper Limb Research Institute
Collaborators
Medtronic, CAS Medical Systems, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
RESEARCH QUESTION There are three research questions correlating with the three research aims; (i) Is cerebral desaturation during shoulder surgery associated with POCD? (ii) Do the FORE-SIGHT® and INVOS™ 5100 devices vary in their measurement of cerebral oxygenation during shoulder surgery in the BCP? (iii) Is there a relationship between cerebral desaturation events during shoulder surgery in the BCP and variables including mean arterial blood pressure, post-operative nausea/vomiting, length of hospital stay, BMI, hypertension and any adverse events?
NULL HYPOTHESES The three null hypotheses are; (i) Cerebral desaturation as measured using cerebral oximetry is not related to POCD after shoulder surgery in the BCP.
(ii) There is no significant difference between the INVOS™ 5100 and the FORE-SIGHT® monitors assessment of cerebral oxygenation during shoulder surgery in the BCP.
(iii) There is no relationship between cerebral desaturation events during shoulder surgery in the BCP and variables including mean arterial blood pressure, the frequency of post-operative nausea/vomiting, length of hospital stay, BMI, hypertension and any adverse events.
PRIMARY HYPOTHESES The primary research hypotheses are; (i) Cerebral desaturation events during surgery in the BCP will be related to POCD.
(ii) The INVOS™ 5100 and the FORE-SIGHT® monitors will show no significant difference in their ability to measure cerebral oxygenation.
(iii) Cerebral desaturation events experienced during shoulder surgery in the BCP are related to a drop in mean arterial blood pressure, an increased likelihood of post-operative nausea and vomiting, greater length of hospital stay, a higher BMI, hypertension and greater frequency of adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgery patients
Arm Type
Experimental
Arm Description
Patients receiving shoulder surgery in the Beach Chair Position, and monitored by both INVOS and FORE-SIGHT monitors.
Intervention Type
Device
Intervention Name(s)
Dual-monitoring
Intervention Description
Monitored using both INVOS and FORE-SIGHT monitors.
Primary Outcome Measure Information:
Title
Trail making test: Delis-Kaplan Executive Function System
Description
The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
Time Frame
Baseline
Title
Trail making test: Delis-Kaplan Executive Function System
Description
The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
Time Frame
1 day post-operative
Title
Trail making test: Delis-Kaplan Executive Function System
Description
The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
Time Frame
8-14 days post-operative
Title
Trail making test: Delis-Kaplan Executive Function System
Description
The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
Time Frame
6 weeks post-operative
Title
Trail making test: Delis-Kaplan Executive Function System
Description
The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
Time Frame
3 months post-operative
Title
Single letter verbal fluency
Description
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.
Time Frame
Baseline
Title
Single letter verbal fluency
Description
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.
Time Frame
1 day post-operative
Title
Single letter verbal fluency
Description
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.
Time Frame
8-14 days post-operative
Title
Single letter verbal fluency
Description
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.
Time Frame
6 weeks post-operative
Title
Single letter verbal fluency
Description
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.
Time Frame
3 months post-operative
Title
Rey Auditory Verbal Learning Test
Description
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.
Time Frame
Baseline
Title
Rey Auditory Verbal Learning Test
Description
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.
Time Frame
1 day post-operative
Title
Rey Auditory Verbal Learning Test
Description
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.
Time Frame
8-14 days post-operative
Title
Rey Auditory Verbal Learning Test
Description
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.
Time Frame
6 weeks post-operative
Title
Rey Auditory Verbal Learning Test
Description
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.
Time Frame
3 months post-operative
Title
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
Description
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.
Time Frame
Baseline
Title
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
Description
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.
Time Frame
1 day post-operative
Title
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
Description
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.
Time Frame
8-14 days post-operative
Title
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
Description
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.
Time Frame
6 weeks post-operative
Title
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
Description
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.
Time Frame
3 months post-operative
Secondary Outcome Measure Information:
Title
Cerebral desaturation events (INVOS)
Description
Cerebral desaturation will be defined as a decrease in regional cerebral oxygen saturation greater than, or equal to 20% from baseline or a fall below 50% absolute.
Time Frame
Intra-operative
Title
Cerebral desaturation events (FORE-SIGHT)
Description
Cerebral desaturation will be defined as a decrease in regional cerebral oxygen saturation greater than, or equal to 20% from baseline or a fall below 50% absolute.
Time Frame
Intra-operative
Title
Mean arterial pressure
Description
Mean arterial blood pressure (mmHg)
Time Frame
Intra-operative
Title
Body Mass Index
Description
Patient Body Mass Index (BMI)
Time Frame
Baseline
Title
Hypertension
Description
Patient-reported hypertension
Time Frame
Baseline
Title
Nausea and vomiting within 48 hours
Description
Patient-reported nausea and vomiting
Time Frame
1 day, 8-14 days
Title
Duration of hospital stay
Description
Patient duration of hospital stay
Time Frame
8-14 days
Title
Adverse events
Description
Any adverse events arising during the trial will be closely monitored and followed up until the resolution of symptoms. These will be checked at each assessment stage and recorded on a data collection form.
Time Frame
Intra-operative
Title
Adverse events
Description
Any adverse events arising during the trial will be closely monitored and followed up until the resolution of symptoms. These will be checked at each assessment
Time Frame
1 day
Title
Adverse events
Description
Any adverse events arising during the trial will be closely monitored and followed up until the resolution of symptoms. These will be checked at each assessment
Time Frame
8-14 days
Title
Adverse events
Description
Any adverse events arising during the trial will be closely monitored and followed up until the resolution of symptoms. These will be checked at each assessment
Time Frame
6 weeks
Title
Adverse events
Description
Any adverse events arising during the trial will be closely monitored and followed up until the resolution of symptoms. These will be checked at each assessment
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Depression Anxiety and Stress Scale-21
Description
The DASS-21 has 21 questions that index the level of depression, anxiety and stress an individual has experienced in the preceding week.
Time Frame
Baseline, 1 day, 8-14 days, 6 weeks, 3 months
Title
Social Relationships and Support Scale
Description
The social support measures address the issues of social process in a range different clinical populations.
Time Frame
Baseline, 1 day, 8-14 days, 6 weeks, 3 months
Title
Loneliness Scale
Description
A standardised 3-item Loneliness scale, comprised of items from the well-validated University of California, Los Angeles (UCLA) Loneliness scale.
Time Frame
Baseline, 1 day, 8-14 days, 6 weeks, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Manzanero, PhD
Phone
+61 7 3834 7069
Email
researchmanager@upperlimb.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Ross, MBBS
Phone
+61 7 3834 6592
Email
markross@upperlimb.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Ross, MBBS
Organizational Affiliation
Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brisbane Hand and Upper Limb Research Institute, Brisbane Private Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Manzanero, PhD
Phone
+61 7 3834 7069
Email
researchmanager@upperlimb.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified cerebral oximeter data acquisition files will be made available to the equipment manufacturers (Medtronic, CASMED) at the conclusion of the study.
Links:
URL
http://www.upperlimb.com
Description
Brisbane Hand and Upper Limb Research Institute
Learn more about this trial
Cerebral Perfusion in the Beach Chair Position
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