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Cerebral Perfusion in the Beach Chair Position

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ClinicalTrials.gov Identifier: NCT03036345
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : January 16, 2019
Sponsor:
Collaborators:
Medtronic
CAS Medical Systems, Inc.
Information provided by (Responsible Party):
Brisbane Hand and Upper Limb Research Institute

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).


Condition or disease Intervention/treatment Phase
Cognitive Dysfunction Device: Dual-monitoring Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prediction of Post-operative Cognitive Decline Following Shoulder Surgery in the Beach Chair Position: The Value of Cerebral Oximetry
Actual Study Start Date : May 25, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: Surgery patients
Patients receiving shoulder surgery in the Beach Chair Position, and monitored by both INVOS and FORE-SIGHT monitors.
Device: Dual-monitoring
Monitored using both INVOS and FORE-SIGHT monitors.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.


Secondary Outcome Measures :
  1. Cerebral desaturation events (INVOS) [ Time Frame: Intra-operative ]
    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.

  2. Cerebral desaturation events (FORE-SIGHT) [ Time Frame: Intra-operative ]
    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.

  3. Mean arterial pressure [ Time Frame: Intra-operative ]
    Mean arterial blood pressure (mmHg)

  4. Body Mass Index [ Time Frame: Baseline ]
    Patient Body Mass Index (BMI)

  5. Hypertension [ Time Frame: Baseline ]
    Patient-reported hypertension

  6. Nausea and vomiting within 48 hours [ Time Frame: 1 day, 8-14 days ]
    Patient-reported nausea and vomiting

  7. Duration of hospital stay [ Time Frame: 8-14 days ]
    Patient duration of hospital stay

  8. Adverse events [ Time Frame: Intra-operative ]
    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.

  9. Adverse events [ Time Frame: 1 day ]
    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

  10. Adverse events [ Time Frame: 8-14 days ]
    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

  11. Adverse events [ Time Frame: 6 weeks ]
    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

  12. Adverse events [ Time Frame: 3 months ]
    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


Other Outcome Measures:
  1. Depression Anxiety and Stress Scale-21 [ Time Frame: Baseline, 1 day, 8-14 days, 6 weeks, 3 months ]
    The DASS-21 has 21 questions that index the level of depression, anxiety and stress an individual has experienced in the preceding week.

  2. Social Relationships and Support Scale [ Time Frame: Baseline, 1 day, 8-14 days, 6 weeks, 3 months ]
    The social support measures address the issues of social process in a range different clinical populations.

  3. Loneliness Scale [ Time Frame: Baseline, 1 day, 8-14 days, 6 weeks, 3 months ]
    A standardised 3-item Loneliness scale, comprised of items from the well-validated University of California, Los Angeles (UCLA) Loneliness scale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036345


Contacts
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Contact: Silvia Manzanero, PhD +61 7 3834 7069 researchmanager@upperlimb.com
Contact: Mark Ross, MBBS +61 7 3834 6592 markross@upperlimb.com

Locations
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Australia, Queensland
Brisbane Hand and Upper Limb Research Institute, Brisbane Private Hospital Recruiting
Brisbane, Queensland, Australia, 4000
Contact: Silvia Manzanero, PhD    +61 7 3834 7069    researchmanager@upperlimb.com   
Sponsors and Collaborators
Brisbane Hand and Upper Limb Research Institute
Medtronic
CAS Medical Systems, Inc.
Investigators
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Principal Investigator: Mark Ross, MBBS Director
  Study Documents (Full-Text)

Documents provided by Brisbane Hand and Upper Limb Research Institute:

Additional Information:
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Responsible Party: Brisbane Hand and Upper Limb Research Institute
ClinicalTrials.gov Identifier: NCT03036345     History of Changes
Other Study ID Numbers: ISR-2016-10757
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders