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Trial registered on ANZCTR


Registration number
ACTRN12622000049774
Ethics application status
Approved
Date submitted
18/11/2021
Date registered
17/01/2022
Date last updated
17/01/2022
Date data sharing statement initially provided
17/01/2022
Date results provided
17/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is there a relationship between processed electroencephalogram (EEG) characteristics during anaesthesia and general level of health?
Scientific title
A preliminary investigation of the relationship between EEG alpha power during anaesthesia and frailty in older adults.
Secondary ID [1] 305814 0
NONE
Universal Trial Number (UTN)
U1111-1271-7134
Trial acronym
EEGLoH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 324342 0
Cognitive ability 324343 0
Physical ability 324344 0
Condition category
Condition code
Mental Health 322053 322053 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Preoperative administration of:
the Montreal Cognitive Assessment (MOCA),
the WHO disability assessment schedule (WHODAS),
the Edmonton Frailty assessment - and
a timed ‘get up & go test’ (TUG).
Administered/overseen by a single study researcher (for consistency) in the hospital setting prior to surgery. The assessments take approximately 30 minutes in total and, excepting the WHODAS, carried out only once.
The WHODAS to be repeated (in-house) at Day 1 post-op and, usually, via telephone at Day 30 post-op. Duration of each follow-up approximately 5-10 minutes.
EEG monitoring will be carried out by the procedural anaesthetist in the normal way and data collection will commence 15 minutes after the induction of anaesthesia and continue for a total of 20 minutes.
Study description: Participants recruited between October 2018 and January 2019. Subjects were surgical candidates 65 years or older. Exclusion criteria included cardiac, neurological, or hip procedures, or inability to complete the initial health assessment questionnaires. Consenting participants completed four assessments: The WHO Disability Assessment Schedule (WHODAS), the Edmonton Frail Scale, the Timed Get Up and Go (TUG) and the Montreal Cognitive Assessment (MoCA). During anaesthesia a Masimo Sedline pEEG monitor was used. Anesthesia management was not standardized. Raw EEG data from the four frontal channels used by Sedline were downloaded and analysed offline. The primary outcome measure was mean absolute alpha power over the 20 min period commencing 15min after induction of anaesthesia. WHODAS was repeated at post-op days 1 & one month.
Intervention code [1] 322220 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329593 0
Mean absolute alpha power, assessed using EEG
Timepoint [1] 329593 0
The 20-minute period beginning 15 minutes after induction of anaesthesia.
Primary outcome [2] 329811 0
Cognitive ability assessed using the Montreal Cognitive Assessment (MOCA)
Timepoint [2] 329811 0
Assessed on day of surgery (DOS) prior to patient presentation to operating theatre.
Primary outcome [3] 329812 0
TUG - assessed on DOS prior to surgery.
Using a stopwatch, the researcher records the time it takes for a patient to rise from chair, walk to a three-metre distant mark on the floor, return to same chair and sit down. The recorded time on the stopwatch from ‘Go’ to reseating is their TUG.TUG score
Timepoint [3] 329812 0
Assessed on day of surgery (DOS) prior to patient presentating to operating theatre.
Secondary outcome [1] 403112 0
Change in activity level, as measured by the WHODAS score. The WHODAS is an internationally-recognised and ratified scoring questionnaire designed to assess the level of ability or disability in the patient's daily living activities.
Timepoint [1] 403112 0
Pre-operative assessment.
Day 1 post-operative.
Day 30 post-operative.

Eligibility
Key inclusion criteria
Patients aged 65 years and over in whom the anaesthetist plans to use processed EEG monitoring. No significant dementia and sufficiently fluent in English to give consent and be able to complete the questionnaires. Patients selected to allow the preoperative assessments to be conducted without delaying surgery.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients undergoing intracranial or cardiac surgery;
Patients with neck of femur fractures;
Patients with significant dementia;
Patients lacking fluency in English.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
We investigated the correlation between the energy of the EEG with the preoperative MOCA and “frailty” scores. We also looked at change in activity level, as measured by the WHODAS score. Given the small numbers, we would not expect to see any correlation with major morbidity or mortality. The EEG was recorded and intensity of spectrogram derived off line. The intensity of the spectrogram was scored on an empirical scale. We used a general linear model, adjusting for differences in age and anaesthetic agent. Excel, GraphPad Prism and R were used for data analysis. Analysis carried out in conjunction with the NZ Brain Research Institute.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/10/2018
Date of last participant enrolment
Anticipated
Actual
30/01/2019
Date of last data collection
Anticipated
Actual
4/03/2019
Sample size
Target
50
Accrual to date
Final
48
Recruitment outside Australia
Country [1] 24329 0
New Zealand
State/province [1] 24329 0

Funding & Sponsors
Funding source category [1] 310162 0
Other Collaborative groups
Name [1] 310162 0
Christchurch Anaesthetists Instrument Pool
Country [1] 310162 0
New Zealand
Primary sponsor type
Hospital
Name
Christchurch Hospital
Address
2 Riccarton Avenue,
Riccarton
Christchurch 8410
South Island
New Zealand
Country
New Zealand
Secondary sponsor category [1] 311247 0
None
Name [1] 311247 0
Address [1] 311247 0
Country [1] 311247 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309851 0
The Northern A Health and Disability Ethics Committee, NZ Health and Disability Ethics Committee
Ethics committee address [1] 309851 0
Ethics committee country [1] 309851 0
New Zealand
Date submitted for ethics approval [1] 309851 0
13/08/2018
Approval date [1] 309851 0
10/09/2018
Ethics approval number [1] 309851 0
18/NTA/140

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115606 0
A/Prof R. Ross Kennedy
Address 115606 0
Specialist Anaesthetist
Department of Anaesthesia
Christchurch Hospital
2 Riccarton Avenue
Riccarton
Christchurch 8410
Country 115606 0
New Zealand
Phone 115606 0
+64 3 3640288
Fax 115606 0
Email 115606 0
ross.kennedy@cdhb.health.nz
Contact person for public queries
Name 115607 0
Margie McKellow
Address 115607 0
Clinical Research Co-ordinator
Clinical Audit Co-ordinator
Department of Anaesthesia
Christchurch Hospital
2 Riccarton Avenue
Riccarton
Christchurch 8410
Country 115607 0
New Zealand
Phone 115607 0
+64 3 3640288
Fax 115607 0
Email 115607 0
margaretta.mckellow@cdhb.health.nz
Contact person for scientific queries
Name 115608 0
R. Ross Kennedy
Address 115608 0
Specialist Anaesthetist
Department of Anaesthesia
Christchurch Hospital
2 Riccarton Avenue
Riccarton
Christchurch 8410
Country 115608 0
New Zealand
Phone 115608 0
+64 3 3640288
Fax 115608 0
Email 115608 0
ross.kennedy@cdhb.health.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will be shared amongst the study team only.
Study results will be shared more widely.
Documents listed below can be made available to other researchers if requested.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14140Other  margie.mckellow@cdhb.health.nz Project Outline available for viewing at link belo... [More Details] 383137-(Uploaded-18-11-2021-09-02-02)-Study-related document.pdf
14141Informed consent form  margie.mckellow@cdhb.health.nz Patient Information Sheet and Informed Consent For... [More Details] 383137-(Uploaded-18-11-2021-08-29-25)-Study-related document.pdf
14143Ethical approval  margie.mckellow@cdhb.health.nz NZ Northern A Health and Disability Ethics Committ... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.