Efficacy and economic evaluation of delivery of care with tele-continuous eeg in critically ill patients : a multicenter randomized controlled trial

Abstract

Some critically ill patients are confirmed by continuous electroencephalography (cEEG) monitoring that non-convulsive seizure (NCS) and/or non-convulsive status epilepticus (NCSE) are causes of their depressed level of consciousness. Meanwhile, the shortage of epilepsy specialists, especially in developing countries, is a major limiting factor in implementing cEEG in general practice. Delivery of care with tele-continuous EEG (tele-cEEG) may be a potential solution as this allows specialists from a central facility to remotely assist local neurologists from distant areas in interpreting EEG findings and suggesting proper treatment. No tele-cEEG program has been implemented to help improve the quality of care. Therefore, this study was conducted to assess the efficacy of implementing tele-cEEG in critical care. Objectives: 1) To ascertain the cumulative incidence of seizures detected by Tele-cEEG and Tele-routine EEG (Tele-rEEG) and 2) To assess the efficacy of Tele-cEEG on mortality and functional outcome as compared with Tele-rEEG Methods: This study was a 3-year prospective, randomized, controlled, parallel, multicentre, superiority trial comparing delivery of care through ‘Tele-cEEG’ intervention with ‘Tele-rEEG’ in patients with clinical suspicion of NCS/NCSE. A group of EEG specialists and a tele-EEG system were set up to remotely interpret EEG findings in eight regional government hospitals across Thailand. The primary outcomes were the detection rate of seizure detected by Tele-cEEG and Tele-rEEG, functional neurological outcome (modified Rankin Scale, mRS), and mortality rate. Functional outcome (mRS) was assessed at 3 and 7 days, and at 90 days, 6 months, 9 months, and 1 year after recruitment. Results: In total, 253 patients were randomized, 127 and 126 patients received Tele-cEEG and Tele-rEEG, respectively. Thirty-three patients with seizure tendency due to the presence of epileptiform discharges in Tele-rEEG arm were switched to receive Tele-cEEG. Overall, NCS and/or NCSE were detected in 46 (18.18%) patients, significantly more common in the Tele-cEEG arm than Tele-rEEG, with corresponding incidence of 22.05% vs 7.94% (p = 0.002). Regarding efficacy on mortality rate, all analyses with adjusting for NCS/NCSE detected and treatments after randomization including intention-to-treat with adjusted HR 0.907 (95% CI: 0.644 – 1.278; p = 0.578), per-protocol with adjusted HR 0.947 (95% CI: 0.650 – 1.379; p = 0.775), modified per-protocol with adjusted HR 1.005 (95% CI: 0.708 – 1.427; p = 0.977) and as-treated analyses with adjusted RR 0.882 (95% CI: 0.638 – 1.125; p = 0.376) did not show significant differences in mortality between Tele-cEEG and Tele-rEEG. Functional scores at > 6 months up to 9 months tended to be better in the Tele-cEEG than Tele-rEEG, i.e., 2.56 vs 3.17 (p = 0.035); however, this was not robust by other analyses, i.e., per-protocol and modified per-protocol analysis. Conclusion: Our findings showed that Tele-cEEG may be beneficial to detect NCS and/or NCSE, but did not improve clinical outcomes relative to Tele-rEEG. In the limited resource setting, we recommend applying at least Tele-rEEG in patients who are at risk for seizure, if there are seizures and/or presence of specific EEG features (i.e., epileptiform and/or periodic discharges) detected during Tele-rEEG recording, continued monitoring with Tele-cEEG may be performed.