From the Division of Clinical Neurophysiology and Division of Neurocritical Care (E.S.R.), Department of Neurology, and Department of Pharmacy (M.E.B.), Massachusetts General Hospital, Boston; Department of Public Health Sciences (J.J.E., J.I.), Medical University of South Carolina, Charleston; Departments of Emergency Medicine (A.J.R., R.S.) and Pediatrics (A.J.R.), University of Michigan, Ann Arbor; Department of Emergency Medicine (T.E.T.), The Ohio State University Wexner Medical Center, Columbus; Division of Pediatric Emergency Medicine (M.H.), Department of Pediatrics, University of Utah, Salt Lake City; Department of Pediatrics (D.G.T.), Medical College of Wisconsin, Milwaukee; Division of Emergency Medicine (L.B.), Department of Pediatrics, University of Cincinnati, OH; Division of Pediatric Emergency Medicine (P.J.O.), Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX; Department of Neurosciences (R.H.L.), Inova Health System, Falls Church, VA; Department of Emergency Medicine (J.B.M.), Henry Ford Hospital, Detroit, MI; Division of Pediatric Emergency Medicine (R.W.H.), Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, PA; Feinberg School of Medicine (T.P.B.), Northwestern University and Rush Medical College, Chicago, IL; Department of Experimental and Clinical Pharmacology (J.C.C., L.D.C.), College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis; Department of Neurology (D.H.L.), University of California, San Francisco; Department of Neurology (J.K.), University of Virginia, Charlottesville; Montefiore Medical Center (S.S.), Albert Einstein College of Medicine, Bronx, NY; and Division of Emergency Medicine (J.M.C.), Children's National Medical Center, Washington, DC.
Neurology. 2021 May 11;96(19):e2372-e2386. doi: 10.1212/WNL.0000000000011879. Epub 2021 Mar 23.
To quantify the association between early neurologic recovery, practice pattern variation, and endotracheal intubation during established status epilepticus, we performed a secondary analysis within the cohort of patients enrolled in the Established Status Epilepticus Treatment Trial (ESETT).
We evaluated factors associated with the endpoint of endotracheal intubation occurring within 120 minutes of ESETT study drug initiation. We defined a blocked, stepwise multivariate regression, examining 4 phases during status epilepticus management: (1) baseline characteristics, (2) acute treatment, (3) 20-minute neurologic recovery, and (4) 60-minute recovery, including seizure cessation and improving responsiveness.
Of 478 patients, 117 (24.5%) were intubated within 120 minutes. Among high-enrolling sites, intubation rates ranged from 4% to 32% at pediatric sites and 19% to 39% at adult sites. Baseline characteristics, including seizure precipitant, benzodiazepine dosing, and admission vital signs, provided limited discrimination for predicting intubation (area under the curve [AUC] 0.63). However, treatment at sites with an intubation rate in the highest (vs lowest) quartile strongly predicted endotracheal intubation independently of other treatment variables (adjusted odds ratio [aOR] 8.12, 95% confidence interval [CI] 3.08-21.4, model AUC 0.70). Site-specific variation was the factor most strongly associated with endotracheal intubation after adjustment for 20-minute (aOR 23.4, 95% CI 6.99-78.3, model AUC 0.88) and 60-minute (aOR 14.7, 95% CI 3.20-67.5, model AUC 0.98) neurologic recovery.
Endotracheal intubation after established status epilepticus is strongly associated with site-specific practice pattern variation, independently of baseline characteristics, and early neurologic recovery and should not alone serve as a clinical trial endpoint in established status epilepticus.
ClinicalTrials.gov Identifier: NCT01960075.
通过对纳入既定癫痫持续状态治疗试验（ESETT）患者队列的二次分析，量化早期神经恢复、实践模式差异与气管插管之间的关联，我们在既定癫痫持续状态期间进行了此项研究。
我们评估了与 ESETT 研究药物开始后 120 分钟内发生气管插管这一终点相关的因素。我们采用分阶段逐步多元回归的方法，检查了癫痫持续状态管理的 4 个阶段：（1）基线特征，（2）急性治疗，（3）20 分钟神经恢复，和（4）60 分钟恢复，包括癫痫发作停止和反应能力改善。
在 478 例患者中，有 117 例（24.5%）在 120 分钟内插管。在高入组率的中心，儿科中心的插管率为 4%至 32%，成人中心为 19%至 39%。基线特征，包括癫痫发作诱因、苯二氮䓬类药物剂量和入院生命体征，对预测插管的作用有限（曲线下面积 [AUC] 0.63）。然而，在插管率最高（vs 最低）四分位数的中心治疗可独立于其他治疗变量预测气管插管（校正比值比 [aOR] 8.12，95%置信区间 [CI] 3.08-21.4，模型 AUC 0.70）。在调整 20 分钟（aOR 23.4，95%CI 6.99-78.3，模型 AUC 0.88）和 60 分钟（aOR 14.7，95%CI 3.20-67.5，模型 AUC 0.98）神经恢复后，与气管插管最相关的是中心特异性变异因素。
既定癫痫持续状态后的气管插管与中心特异性实践模式的差异密切相关，独立于基线特征和早期神经恢复，不应单独作为既定癫痫持续状态临床试验的终点。
ClinicalTrials.gov 标识符：NCT01960075。
