Efficacy of delivery of care with Tele-continuous EEG in critically ill patients: a multicenter randomized controlled trial (Tele-cRCT study) study

Abstract

Background: Continuous electroencephalography (cEEG) has been recommended in critically ill patients although its efficacy for improving patients’ functional status remains unclear. This study aimed to compare the efficacy of Tele-cEEG with Tele-routine EEG (Tele-rEEG), in terms of seizure detection rate, mortality and functional outcomes. Methods: This study is a 3-year randomized, controlled, parallel, multicenter trial, conducted in eight regional hospitals across Thailand. Eligible participants were critically ill patients aged ≥ 15 years and at-risk for developing nonconvulsive seizure (NCS)/nonconvulsive status epilepticus (NCSE). Study interventions were 24–72 h Tele-cEEG versus 30-min Tele-rEEG. Study outcomes were seizure detection rate, mortality and functional outcomes (mRS), assessed at hospital discharge, ≤ 7 days, 3-, 6-, 9-months and 1 year. Results: Two hundred and fifty-four patients were randomized, 128 and 126 patients received Tele-cEEG and Tele-rEEG, respectively. NCS/NCSE were detected more commonly in the Tele-cEEG (21.88%) than Tele-rEEG arm (14.29%) but this was not statistically significant (p = 0.116). Intention-to-treat, per-protocol and as-treated analysis showed non-significant differences in mortality at all assessment periods, with corresponding mortality rates of 10.03% (Tele-cEEG) versus 10.10% (Tele-rEEG) (p = 0.894), 9.67% versus 9.06% (p = 0.833) and 10.34% versus 9.06% (p = 0.600), respectively. Functional outcome was also not significantly different in all analyses. Conclusions: Both Tele-cEEG and Tele-rEEG are feasible, although Tele-EEG requires additional EEG specialists, budget, and computational resources. While Tele-cEEG may help detect NCS/NCSE, this study had limited power to detect its efficacy in reducing mortality or improving functional outcomes. In limited-resource settings, Tele-rEEG approximating 30 min or longer offers a feasible and potentially valuable initial screening tool for critically ill patients at-risk of seizures. However, where Tele-cEEG is readily available, it remains the recommended approach. Trial registration Thai Clinical Trials Registry (TTCTR20181022002); Registered 22 October 2018.