A prospective randomized controlled trial to evaluate two approaches for EEG application on the incidence of electrode-induced skin injury among ambulatory EEG patients

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.