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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03036345
Registration number
NCT03036345
Ethics application status
Date submitted
29/12/2016
Date registered
30/01/2017
Titles & IDs
Public title
Cerebral Perfusion in the Beach Chair Position
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Scientific title
Prediction of Post-operative Cognitive Decline Following Shoulder Surgery in the Beach Chair Position: The Value of Cerebral Oximetry
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Secondary ID [1]
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ISR-2016-10757
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cognitive Dysfunction
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Condition category
Condition code
Mental Health
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Dual-monitoring
Experimental: Surgery patients - Patients receiving shoulder surgery in the Beach Chair Position, and monitored by both INVOS and FORE-SIGHT monitors.
Treatment: Devices: Dual-monitoring
Monitored using both INVOS and FORE-SIGHT monitors.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Trail making test: Delis-Kaplan Executive Function System
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Assessment method [1]
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The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
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Timepoint [1]
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Baseline
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Primary outcome [2]
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Trail making test: Delis-Kaplan Executive Function System
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Assessment method [2]
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The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
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Timepoint [2]
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1 day post-operative
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Primary outcome [3]
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Trail making test: Delis-Kaplan Executive Function System
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Assessment method [3]
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The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
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Timepoint [3]
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8-14 days post-operative
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Primary outcome [4]
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Trail making test: Delis-Kaplan Executive Function System
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Assessment method [4]
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The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
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Timepoint [4]
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6 weeks post-operative
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Primary outcome [5]
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Trail making test: Delis-Kaplan Executive Function System
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Assessment method [5]
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The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
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Timepoint [5]
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3 months post-operative
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Primary outcome [6]
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Single letter verbal fluency
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline
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Primary outcome [7]
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Single letter verbal fluency
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Assessment method [7]
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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.
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Timepoint [7]
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1 day post-operative
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Primary outcome [8]
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Single letter verbal fluency
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Assessment method [8]
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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.
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Timepoint [8]
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8-14 days post-operative
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Primary outcome [9]
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Single letter verbal fluency
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Assessment method [9]
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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.
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Timepoint [9]
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6 weeks post-operative
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Primary outcome [10]
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Single letter verbal fluency
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Assessment method [10]
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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.
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Timepoint [10]
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3 months post-operative
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Primary outcome [11]
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Rey Auditory Verbal Learning Test
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline
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Primary outcome [12]
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Rey Auditory Verbal Learning Test
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Assessment method [12]
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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.
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Timepoint [12]
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1 day post-operative
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Primary outcome [13]
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Rey Auditory Verbal Learning Test
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Assessment method [13]
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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.
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Timepoint [13]
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8-14 days post-operative
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Primary outcome [14]
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Rey Auditory Verbal Learning Test
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Assessment method [14]
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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.
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Timepoint [14]
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6 weeks post-operative
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Primary outcome [15]
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Rey Auditory Verbal Learning Test
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Assessment method [15]
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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.
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Timepoint [15]
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3 months post-operative
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Primary outcome [16]
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Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
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Assessment method [16]
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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.
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Timepoint [16]
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Baseline
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Primary outcome [17]
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Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
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Assessment method [17]
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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.
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Timepoint [17]
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1 day post-operative
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Primary outcome [18]
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Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
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Assessment method [18]
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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.
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Timepoint [18]
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8-14 days post-operative
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Primary outcome [19]
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Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
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Assessment method [19]
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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.
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Timepoint [19]
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6 weeks post-operative
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Primary outcome [20]
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Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
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Assessment method [20]
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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.
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Timepoint [20]
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3 months post-operative
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Secondary outcome [1]
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Cerebral desaturation events (INVOS)
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Assessment method [1]
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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.
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Timepoint [1]
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Intra-operative
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Secondary outcome [2]
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Cerebral desaturation events (FORE-SIGHT)
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Assessment method [2]
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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.
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Timepoint [2]
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Intra-operative
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Secondary outcome [3]
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Mean arterial pressure
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Assessment method [3]
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Mean arterial blood pressure (mmHg)
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Timepoint [3]
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Intra-operative
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Secondary outcome [4]
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Body Mass Index
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Assessment method [4]
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Patient Body Mass Index (BMI)
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Timepoint [4]
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Baseline
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Secondary outcome [5]
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Hypertension
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Assessment method [5]
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Patient-reported hypertension
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Timepoint [5]
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Baseline
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Secondary outcome [6]
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Nausea and vomiting within 48 hours
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Assessment method [6]
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Patient-reported nausea and vomiting
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Timepoint [6]
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1 day, 8-14 days
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Secondary outcome [7]
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Duration of hospital stay
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Assessment method [7]
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Patient duration of hospital stay
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Timepoint [7]
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8-14 days
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Secondary outcome [8]
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Adverse events
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Assessment method [8]
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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.
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Timepoint [8]
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Intra-operative
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Secondary outcome [9]
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Adverse events
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Assessment method [9]
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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
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Timepoint [9]
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1 day
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Secondary outcome [10]
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Adverse events
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Assessment method [10]
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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
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Timepoint [10]
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8-14 days
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Secondary outcome [11]
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Adverse events
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Assessment method [11]
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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
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Timepoint [11]
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6 weeks
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Secondary outcome [12]
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Adverse events
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Assessment method [12]
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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
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Timepoint [12]
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3 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/05/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2020
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Brisbane Hand and Upper Limb Research Institute, Brisbane Private Hospital - Brisbane
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Recruitment postcode(s) [1]
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4000 - Brisbane
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Funding & Sponsors
Primary sponsor type
Other
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Name
Brisbane Hand and Upper Limb Research Institute
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Medtronic
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Address [1]
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Country [1]
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Other collaborator category [2]
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Commercial sector/industry
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Name [2]
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CAS Medical Systems, Inc.
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT03036345
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mark Ross, MBBS
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Address
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Director
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Silvia Manzanero, PhD
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Address
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Country
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Phone
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+61 7 3834 7069
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Deidentified cerebral oximeter data acquisition files will be made available to the equipment manufacturers (Medtronic, CASMED) at the conclusion of the study.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Informed Consent Form
https://cdn.clinicaltrials.gov/large-docs/45/NCT03036345/Prot_ICF_000.pdf
Informed consent form
Study Protocol and Informed Consent Form
https://cdn.clinicaltrials.gov/large-docs/45/NCT03036345/Prot_ICF_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03036345