Efficacy of delivery of care with Tele-continuous EEG in critically ill patients: a multicenter randomized controlled trial (Tele-cRCT study) study
Abstract
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. 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. 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.…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 128 participants or records.
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