远程持续脑电图在危重症患者护理中的疗效：一项多中心随机对照试验（远程cRCT研究）

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

作者信息

Limotai Chusak, Jirasakuldej Suda, Wongwiangiunt Sattawut, Tumnark Tipakorn, Suwanpakdee Piradee, Wangponpattanasiri Kwuanrat, Rakchue Piyanuch, Tungkasereerak Chaiwiwat, Pleumpanupatand Polchai, Tansuhaj Phopsuk, Ekkachon Phattarawin, Kittipanprayoon Songchai, Kerddonfag Apiwoot, Pobsuk Thippamas, Pattanateepapon Anuchate, Phanthumchinda Kammant, Suwanwela Nijasri C, Thaipisuttikul Iyavut, Boonyapisit Kanokwan, Ingsathit Atiporn, Pattanaprateep Oraluck, Attia John, McKay Gareth J, Rossetti Andrea O, Thakkinstian Ammarin, Rukrung Chutima, Kangsananont Patcharapun, Mokkaew Jeerawan, Phayaph Nittaya, Pukpraman Supak, Ritrhathon Warangkana, Jarungjitapinan Youwarat, Pinpradab Jintana, Khamhoi Netphit, Nookaew Mayuree, Chauywang Patchareeporn, Rojdmapitayakorn Pichai, Sribussara Paworamon, Tinroongroj Wasunon, Teeratantikanon Wisan, Chongsuvivatwong Tabtim, Viratyaporn Watchara, Jantararotai Witoon, Panyawattanakit Komkrit, Rujirarongrueng Nopparat, Damthong Pornnapat, Udom Pattama, Siengsuwan Molvipa, Phonprasori Phatcharamai, Wanmuang Karnpidcha, Unwanatham Nattawut, Rattanasiri Sasivimol, Thadanipon Kunlawat, Noivong Panutchaya, Pitipanyakul Sirincha, Rattanachaisit Watchara, Muangthong Wichuta, Wittayawisawasakul Rachasiri, Deerassamee Sunisa, Ruayruen Wannaporn, Homgrunjarut Supinya, Deerassamee Sunisa, Ledprased Yupapron, Pankong Maturos, Rattanayuvakorn Pentip

机构信息

Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Rama VI Road, Rachatevi, Bangkok, 10400, Thailand.

Chulalongkorn Comprehensive Epilepsy Center of Excellence, The Thai Red Cross Society, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.

出版信息

Crit Care. 2025 Jan 7;29(1):15. doi: 10.1186/s13054-024-05246-x.

DOI:10.1186/s13054-024-05246-x

PMID:39773282

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11707894/

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.

摘要

背景

尽管持续脑电图（cEEG）对改善重症患者功能状态的疗效尚不清楚，但已被推荐用于此类患者。本研究旨在比较远程cEEG与远程常规脑电图（Tele-rEEG）在癫痫检测率、死亡率和功能结局方面的疗效。

方法

本研究是一项为期3年的随机、对照、平行、多中心试验，在泰国的8家地区医院进行。符合条件的参与者为年龄≥15岁且有发生非惊厥性癫痫（NCS）/非惊厥性癫痫持续状态（NCSE）风险的重症患者。研究干预措施为24 - 72小时的远程cEEG与30分钟的Tele-rEEG。研究结局为癫痫检测率、死亡率和功能结局（改良Rankin量表），在出院时、≤7天、3个月、6个月、9个月和1年时进行评估。

结果

254例患者被随机分组，分别有128例和126例患者接受了远程cEEG和Tele-rEEG。远程cEEG组（21.88%）比Tele-rEEG组（14.29%）更常检测到NCS/NCSE，但差异无统计学意义（p = 0.116）。意向性分析、符合方案分析和实际治疗分析显示，在所有评估期死亡率均无显著差异，相应死亡率分别为10.03%（远程cEEG）对10.10%（Tele-rEEG）（p = 0.894）、9.67%对9.06%（p = 0.833）和10.34%对9.06%（p = 0.600）。在所有分析中，功能结局也无显著差异。

结论

远程cEEG和Tele-rEEG都是可行的，尽管远程脑电图需要额外的脑电图专家、预算和计算资源。虽然远程cEEG可能有助于检测NCS/NCSE，但本研究检测其降低死亡率或改善功能结局疗效的能力有限。在资源有限的环境中，约30分钟或更长时间的Tele-rEEG为有癫痫发作风险的重症患者提供了一种可行且可能有价值的初始筛查工具。然而，在可随时获得远程cEEG的情况下，它仍是推荐的方法。试验注册泰国临床试验注册中心（TTCTR20181022002）；2018年10月22日注册。