Eric S Rosenthal1, Jordan J Elm2, James Ingles2, Alexander J Rogers2, Thomas E Terndrup2, Maija Holsti2, Danny G Thomas2, Lynn Babcock2, Pamela J Okada2, Robert H Lipsky2, Joseph B Miller2, Robert W Hickey2, Megan E Barra2, Thomas P Bleck2, James C Cloyd2, Robert Silbergleit2, Daniel H Lowenstein2, Lisa D Coles2, Jaideep Kapur2, Shlomo Shinnar2, James M Chamberlain2. 1. 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. erosenthal@mgh.harvard.edu. 2. 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.
Abstract
OBJECTIVE: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov Identifier: NCT01960075.
OBJECTIVE: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov Identifier: NCT01960075.
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