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Trial registered on ANZCTR


Registration number
ACTRN12620001157965
Ethics application status
Approved
Date submitted
1/10/2020
Date registered
4/11/2020
Date last updated
16/08/2022
Date data sharing statement initially provided
4/11/2020
Date results provided
16/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective randomized controlled trial to evaluate two approaches for EEG application on the incidence of electrode-induced skin injury among ambulatory EEG patients
Scientific title
A Prospective Randomized Controlled trial of a mixed electrode (standard + hydrogel) approach to EEG application versus a standard approach (standard electrodes only), to the incidence of electrode-induced skin injury among ambulatory EEG patients
Secondary ID [1] 302407 0
None
Universal Trial Number (UTN)
U1111-1258-8007
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin injury 319204 0
Condition category
Condition code
Injuries and Accidents 317169 317169 0 0
Other injuries and accidents
Skin 317170 317170 0 0
Other skin conditions
Neurological 317508 317508 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aim: To compare skin injury related to EEG electrode application using Ten 20 paste with Tensive adhesive gel versus mixed EEG electrodes with hydrogel electrodes.

A prospective, randomized controlled intervention study will be conducted: From November 2020 to May 2021 in the Ambulatory Care Unit at Royal Prince Alfred Hospital. Following attendance at the clinic, patients will be randomized into two groups. Group 1 (Standard Care Group) will receive standard electrodes affixed with Ten-20 conductive paste with tensive adhesive gel. Group 2 (Active Care Group) will receive Ten-20 conductive paste with tensive adhesive gel mixed with the use of hydrogel electrodes in frontal and hairless regions on the scalp.
All patients will be monitored for four days. They will be required to attend the Neuroscience Ambulatory Care Unit twice after the application of EEG electrodes:
i) post-application of EEG (day 2): 30 minutes for changing batteries and checking the electrodes placement
ii) on EEG electrodes removal day (day 4): 30minutes for removing the electrodes, answering the survey; taking the pictures of the scalp
The patients are required to return to the clinic on the day 2 post application for changing batteries, checking the replacement, and repositioning of the electrodes repositioning of the frontal pole electrodes (Fp1 & Fp2) for the group 1. The frontal electrodes in Group 2 are not removed unless there is dislodgement. The nurses will assess their scalps before application of EEG electrodes. When they return on EEG removal day (day 4), the nurses will remove all EEG electrodes and will take pictures of their scalps. The nurse will also ask them to complete a self-report questionnaire for evaluating the tolerability of ambulatory EEG monitoring. This questionnaire will take you 5 minutes to complete.
All patients will be required to return the clinic any time during their home monitoring if the recording device turns off or electrode dislodgements occur.
Two trained neurophysiology nurses will assess consecutive patients. One nurse will complete the pre-application assessment form while the other nurse will apply the EEG electrodes. The nurses will assess the skin condition at the 23 EEG electrode sites on the day of electrode removal (day4) and take digital photographs of the scalp of the patients. A nurse who is not involved in the EEG application process will complete the skin assessment tool in a blinded fashion by reviewing un-notated photographs only. This nurse will have no knowledge of the intervention allocation schedule, which will be maintained by the study nurses.
All the nurses who will be involved in performing ambulatory EEG testing will receive training about the study protocol before commencing the research. We will outline a step-by-step process in performing the AEEG testing, to be best positioned to have uniformity in preparing the skin and performing the test. A training log for the nurses who will be performing the test will be maintained.
Intervention code [1] 318693 0
Prevention
Comparator / control treatment
Group 1 (Standard electrodes, affixed with Ten-20 with Tensive gel): After the skin preparation, the nurses will apply the disposable EEG electrodes onto the scalp by using Ten-20 conductive paste; then cover the electrodes with a small amount of tensive adhesive gel and hypafix tape for securing the electrodes. The nurse then will place a small square of soft rubber cushion under the frontal electrode hubs and will connect the electrode wires to the recording device to check the impedance of the electrodes (aiming for less than 10 K Ohm).
Control group
Active

Outcomes
Primary outcome [1] 325250 0
The primary outcomes are to evaluate the effectiveness of the mixed electrode approach using hydrogel electrodes to reduce electrode related skin injury in the patients who require AEEG monitoring for 4 days.
The photographs of the patients will be assessed by a skin assessment tool which utilizes skin injury scale: 1= Minimal erythema, 2= Moderate erythema with sharply defined borders, 3= Intense erythema with or without edema, 4= Intense erythema with edema and blistering/erosion.
Timepoint [1] 325250 0
Baseline (before application of electrodes) and last day (Day 4) of AEEG monitoring
Primary outcome [2] 325547 0
EEG data quality is assessed by EEG quality data scale (0-5, 0 indicates poor EEG recording quality and 5 indicates good EEG recording quality).
Timepoint [2] 325547 0
Baseline (first day of AEEG monitoring) and last day (Day 4) of AEEG monitoring
Secondary outcome [1] 387337 0
A secondary outcome of interest is tolerability of AEEG monitoring. assessed by providing a survey to the patients on the day of EEG electrode removal. The survey consists of four self-reported questions which seek Likert scale responses.
Timepoint [1] 387337 0
Baseline (before application of electrodes ) and last day (Day 4) of AEEG monitoring
Secondary outcome [2] 388358 0
A secondary outcome of interest is patient mood during AEEG monitoring assessed by providing a survey to the patients on the day of EEG electrode removal. The survey consists of four self-reported questions which seek Likert scale responses.
Timepoint [2] 388358 0
Baseline (before application of electrodes) and last day (Day 4) of AEEG monitoring

Eligibility
Key inclusion criteria
All patients are eligible for this study if they are older than 18 years of age and have valid neurologist referrals for AEEG monitoring for four days.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients have skin irritation/inflammation or headlice on their scalp;
* Patients are allergic to Ten-20 conductive paste, Tensive gel or hydrogel;
* Patients are confused or agitated;
* Patients are unable to tolerate AEEG monitoring;
* Patients are less than 18 or more than 90 years of age.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The administrative officer will prepare a sealed envelope which will record the patient’s name and the group they have been allocated to. This envelope will only be opened by the study nurse who is charged with applying the electrodes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple 1 to 1 ratio randomization will be utilized by a software program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We calculated the sample size needed for this study, based on previously obtained skin injury rates of 65.1 % (Ouchida et al., 2020). To have an 80% chance of detecting a by-group difference in the incidence of the outcome of 35 % or more, at the P<0.05 level, we need to have a total of 72 patients: 36 patients in each group.
Univariate statistical analyses will be employed to assess equivalence between the two groups. Repeat measures analyses of variance (SPSS General Linear Model Repeat Measures Procedure) will be employed to describe and compare skin irritation change from baseline to endpoint. Multivariate statistical analyses will be employed to assess the effects of covariates on by-group outcome comparisons.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/11/2020
Actual
23/11/2020
Date of last participant enrolment
Anticipated
26/04/2021
Actual
31/05/2021
Date of last data collection
Anticipated
30/04/2021
Actual
4/06/2021
Sample size
Target
72
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17655 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 31501 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 306420 0
Hospital
Name [1] 306420 0
Royal Prince Alfred Hospital
Country [1] 306420 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Royal Prince Alfred Hospital
Comprehensive epilepsy service
50 Missenden Road
Camperdown, Sydney
NSW 2050
Country
Australia
Secondary sponsor category [1] 307389 0
None
Name [1] 307389 0
Address [1] 307389 0
Country [1] 307389 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306617 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 306617 0
Ethics committee country [1] 306617 0
Australia
Date submitted for ethics approval [1] 306617 0
15/08/2020
Approval date [1] 306617 0
24/09/2020
Ethics approval number [1] 306617 0
: X20-0355

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

Contacts
Principal investigator
Name 104482 0
A/Prof Armin Nikpour
Address 104482 0
Royal Prince Alfred Hospital & The University of Sydney
COMPREHENSIVE EPILEPSY SERVICE
50 Missenden Road, CAMPERDOWN, NSW 2050
AUSTRALIA
Country 104482 0
Australia
Phone 104482 0
+61295157558
Fax 104482 0
+61295157771
Email 104482 0
armin@sydneyneurology.com.au
Contact person for public queries
Name 104483 0
Sumika Ouchida
Address 104483 0
Royal Prince Alfred Hospital & The University of Sydney
COMPREHENSIVE EPILEPSY SERVICE
50 Missenden Road, CAMPERDOWN, NSW 2050
AUSTRALIA
Country 104483 0
Australia
Phone 104483 0
+61295153928
Fax 104483 0
+61295157771
Email 104483 0
sumika.ouchida@health.nsw.gov.au
Contact person for scientific queries
Name 104484 0
Sumika Ouchida
Address 104484 0
Royal Prince Alfred Hospital & The University of Sydney
COMPREHENSIVE EPILEPSY SERVICE
50 Missenden Road, CAMPERDOWN, NSW 2050
AUSTRALIA
Country 104484 0
Australia
Phone 104484 0
+61295153928
Fax 104484 0
+61295157771
Email 104484 0
sumika.ouchida@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The entire dataset
When will data be available (start and end dates)?
The data will be available for 5 years after publication.
Available to whom?
Authorised meta-analysts who have sought ethical approval to access the data
Available for what types of analyses?
Meta-analytic
How or where can data be obtained?
From Coordinator (Sumika.ouchida@health.nsw. gov.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9303Ethical approval    380356-(Uploaded-26-09-2020-11-38-39)-Study-related document.PDF



Results publications and other study-related documents

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

Documents added automatically
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