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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
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
Not applicable
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
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03036345