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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03036345




Registration number
NCT03036345
Ethics application status
Date submitted
29/12/2016
Date registered
30/01/2017
Date last updated
16/01/2019

Titles & IDs
Public title
Cerebral Perfusion in the Beach Chair Position
Scientific title
Prediction of Post-operative Cognitive Decline Following Shoulder Surgery in the Beach Chair Position: The Value of Cerebral Oximetry
Secondary ID [1] 0 0
ISR-2016-10757
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Dysfunction 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Trail making test: Delis-Kaplan Executive Function System
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Trail making test: Delis-Kaplan Executive Function System
Timepoint [2] 0 0
1 day post-operative
Primary outcome [3] 0 0
Trail making test: Delis-Kaplan Executive Function System
Timepoint [3] 0 0
8-14 days post-operative
Primary outcome [4] 0 0
Trail making test: Delis-Kaplan Executive Function System
Timepoint [4] 0 0
6 weeks post-operative
Primary outcome [5] 0 0
Trail making test: Delis-Kaplan Executive Function System
Timepoint [5] 0 0
3 months post-operative
Primary outcome [6] 0 0
Single letter verbal fluency
Timepoint [6] 0 0
Baseline
Primary outcome [7] 0 0
Single letter verbal fluency
Timepoint [7] 0 0
1 day post-operative
Primary outcome [8] 0 0
Single letter verbal fluency
Timepoint [8] 0 0
8-14 days post-operative
Primary outcome [9] 0 0
Single letter verbal fluency
Timepoint [9] 0 0
6 weeks post-operative
Primary outcome [10] 0 0
Single letter verbal fluency
Timepoint [10] 0 0
3 months post-operative
Primary outcome [11] 0 0
Rey Auditory Verbal Learning Test
Timepoint [11] 0 0
Baseline
Primary outcome [12] 0 0
Rey Auditory Verbal Learning Test
Timepoint [12] 0 0
1 day post-operative
Primary outcome [13] 0 0
Rey Auditory Verbal Learning Test
Timepoint [13] 0 0
8-14 days post-operative
Primary outcome [14] 0 0
Rey Auditory Verbal Learning Test
Timepoint [14] 0 0
6 weeks post-operative
Primary outcome [15] 0 0
Rey Auditory Verbal Learning Test
Timepoint [15] 0 0
3 months post-operative
Primary outcome [16] 0 0
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
Timepoint [16] 0 0
Baseline
Primary outcome [17] 0 0
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
Timepoint [17] 0 0
1 day post-operative
Primary outcome [18] 0 0
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
Timepoint [18] 0 0
8-14 days post-operative
Primary outcome [19] 0 0
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
Timepoint [19] 0 0
6 weeks post-operative
Primary outcome [20] 0 0
Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
Timepoint [20] 0 0
3 months post-operative
Secondary outcome [1] 0 0
Cerebral desaturation events (INVOS)
Timepoint [1] 0 0
Intra-operative
Secondary outcome [2] 0 0
Cerebral desaturation events (FORE-SIGHT)
Timepoint [2] 0 0
Intra-operative
Secondary outcome [3] 0 0
Mean arterial pressure
Timepoint [3] 0 0
Intra-operative
Secondary outcome [4] 0 0
Body Mass Index
Timepoint [4] 0 0
Baseline
Secondary outcome [5] 0 0
Hypertension
Timepoint [5] 0 0
Baseline
Secondary outcome [6] 0 0
Nausea and vomiting within 48 hours
Timepoint [6] 0 0
1 day, 8-14 days
Secondary outcome [7] 0 0
Duration of hospital stay
Timepoint [7] 0 0
8-14 days
Secondary outcome [8] 0 0
Adverse events
Timepoint [8] 0 0
Intra-operative
Secondary outcome [9] 0 0
Adverse events
Timepoint [9] 0 0
1 day
Secondary outcome [10] 0 0
Adverse events
Timepoint [10] 0 0
8-14 days
Secondary outcome [11] 0 0
Adverse events
Timepoint [11] 0 0
6 weeks
Secondary outcome [12] 0 0
Adverse events
Timepoint [12] 0 0
3 months

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
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2020
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Brisbane Hand and Upper Limb Research Institute, Brisbane Private Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4000 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
Brisbane Hand and Upper Limb Research Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Medtronic
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
CAS Medical Systems, Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03036345
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark Ross, MBBS
Address 0 0
Director
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Silvia Manzanero, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 7 3834 7069
Fax 0 0
Email 0 0
researchmanager@upperlimb.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT03036345