Cognitive DysfunctionNCT03036345
Cerebral Perfusion in the Beach Chair Position
A study testing Dual-monitoring in people with Cognitive Dysfunction, run by Brisbane Hand and Upper Limb Research Institute at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- Dual-monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- 25 May 2017to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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*
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Brisbane Hand and Upper Limb Research Institute, Brisbane Private Hospital
Brisbane, Queensland, 4000
Silvia Manzanero, PhD, +61 7 3834 7069, researchmanager@upperlimb.com
About this study
Official title: Prediction of Post-operative Cognitive Decline Following Shoulder Surgery in the Beach Chair Position: The Value of Cerebral Oximetry
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).
Read the 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.
- Conditions
- Cognitive Dysfunction
- Being tested
- Dual-monitoring
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-monitoringDevice
Monitored using both INVOS and FORE-SIGHT monitors.
| Study group | Role | What they receive |
|---|---|---|
| Surgery patients | Experimental | Patients receiving shoulder surgery in the Beach Chair Position, and monitored by both INVOS and FORE-SIGHT monitors. Receives: Device: Dual-monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months post-operative
Secondary outcomes (12)
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.
Measured: Intra-operative
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.
Measured: Intra-operative
Mean arterial pressure
Mean arterial blood pressure (mmHg)
Measured: Intra-operative
Body Mass Index
Patient Body Mass Index (BMI)
Measured: Baseline
Hypertension
Patient-reported hypertension
Measured: Baseline
Nausea and vomiting within 48 hours
Patient-reported nausea and vomiting
Measured: 1 day, 8-14 days
Duration of hospital stay
Patient duration of hospital stay
Measured: 8-14 days
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.
Measured: Intra-operative
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
Measured: 1 day
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
Measured: 8-14 days
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
Measured: 6 weeks
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start25 May 2017
- Primary completionDec 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brisbane Hand and Upper Limb Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, CAS Medical Systems, Inc.
- Responsible party
- Sponsor
- Investigators
- Mark Ross, MBBS, Principal investigator, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036345
- Sponsor's protocol ID
- ISR-2016-10757
- Status last verified
- Jan 2019
- First submitted
- 29 Dec 2016
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified cerebral oximeter data acquisition files will be made available to the equipment manufacturers (Medtronic, CASMED) at the conclusion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Post-operative Cognitive Decline Following Shoulder Surgery in the Beach Chair Position: The Value of Cerebral Oximetry
- ClinicalTrials.gov ID
- NCT03036345
- Acronym / sponsor ID
- ISR-2016-10757
- Conditions
- Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Brisbane Hand and Upper Limb Research InstituteUniversity, hospital or other
- Collaborators
- Medtronic, CAS Medical Systems, Inc.
- Study start
- 25 May 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery patients | Experimental | Device: Dual-monitoringPatients receiving shoulder surgery in the Beach Chair Position, and monitored by both INVOS and FORE-SIGHT monitors. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-monitoringMonitored using both INVOS and FORE-SIGHT monitors. | Device | Surgery patients |
Primary outcome
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.
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.
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.
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: 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.
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.
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.
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.
12 secondary outcomes
Cerebral desaturation events (INVOS)
Time frame: Intra-operative
Cerebral desaturation events (FORE-SIGHT)
Time frame: Intra-operative
Mean arterial pressure
Time frame: Intra-operative
Body Mass Index
Time frame: Baseline
Hypertension
Time frame: Baseline
Nausea and vomiting within 48 hours
Time frame: 1 day, 8-14 days
Duration of hospital stay
Time frame: 8-14 days
Adverse events
Time frame: Intra-operative
Adverse events
Time frame: 1 day
Adverse events
Time frame: 8-14 days
Adverse events
Time frame: 6 weeks
Adverse events
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Brisbane Hand and Upper Limb Research InstituteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Ross, MBBS principal investigator
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-monitoring in people with Cognitive Dysfunction, run by Brisbane Hand and Upper Limb Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Manzanero, PhD (+61 7 3834 7069, researchmanager@upperlimb.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trail making test: Delis-Kaplan Executive Function System (time frame: Baseline). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.