Craig S Anderson1, Hisatomi Arima1, Pablo Lavados1, Laurent Billot1, Maree L Hackett1, Verónica V Olavarría1, Paula Muñoz Venturelli1, Alejandro Brunser1, Bin Peng1, Liying Cui1, Lily Song1, Kris Rogers1, Sandy Middleton1, Joyce Y Lim1, Denise Forshaw1, C Elizabeth Lightbody1, Mark Woodward1, Octavio Pontes-Neto1, H Asita De Silva1, Ruey-Tay Lin1, Tsong-Hai Lee1, Jeyaraj D Pandian1, Gillian E Mead1, Thompson Robinson1, Caroline Watkins1. 1. From the George Institute for Global Health (C.S.A., H.A., L.B., M.L.H., P.M.V., K.R., J.Y.L., M.W.) and Faculty of Medicine (C.S.A., L.B., M.L.H., L.S., K.R., J.Y.L., M.W.), University of New South Wales, the Neurology Department, Royal Prince Alfred Hospital, Sydney Health Partners (C.S.A.), the Nursing Research Institute, St. Vincent's Health (S.M.), and Australian Catholic University (S.M., C.W.) - all in Sydney; the George Institute China at Peking University Health Science Center (C.S.A., L.S.) and the Department of Neurology, Peking Union Medical College Hospital (B.P., L.C.) Beijing, and the Department of Neurology, 85 Hospital of People's Liberation Army, Shanghai (L.S.) - all in China; the Department of Preventive Medicine and Public Health, Faculty of Medicine, Fukuoka University, Fukuoka, Japan (H.A.); the Department of Neurology and Psychiatry, Clínica Alemana de Santiago (P.L., V.V.O., P.M.V., A.B.), Facultad de Medicina, Clínica Alemana Universidad del Desarrollo (P.L.), and Departamento de Ciencias Neurológicas, Facultad de Medicina, Universidad de Chile (P.L.) - all in Santiago, Chile; the College of Health and Wellbeing, University of Central Lancashire, Preston (M.L.H., D.F., C.E.L., C.W.), the George Institute for Global Health, University of Oxford (M.W.), the Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh (G.E.M.), and the Department of Cardiovascular Sciences and NIHR Biomedical Research Unit, University of Leicester, Leicester (T.R.) - all in the United Kingdom; the Department of Epidemiology, Johns Hopkins University, Baltimore (M.W.); the Stroke Service-Neurology Division, Department of Neuroscience and Behavior, Ribeirão Preto School of Medicine, University of São Paulo, São Paulo (O.P.-N.); the Clinical Trials Unit, Department of Pharmacology, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka (H.A.D.S.); the Department of Neurology, Christian Medical College, Ludhiana, India (J.D.P.); and the Department of Neurology, Kaohsiung Medical University and Hospital, Kaohsiung (R.-T.L.), and the Stroke Center and Department of Neurology, Linkou Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Taoyuan (T.-H.L.) - both in Taiwan.
Abstract
BACKGROUND: The role of supine positioning after acute stroke in improving cerebral blood flow and the countervailing risk of aspiration pneumonia have led to variation in head positioning in clinical practice. We wanted to determine whether outcomes in patients with acute ischemic stroke could be improved by positioning the patient to be lying flat (i.e., fully supine with the back horizontal and the face upwards) during treatment to increase cerebral perfusion. METHODS: In a pragmatic, cluster-randomized, crossover trial conducted in nine countries, we assigned 11,093 patients with acute stroke (85% of the strokes were ischemic) to receivecare in either a lying-flat position or a sitting-up position with the head elevated to at least 30 degrees, according to the randomization assignment of the hospital to which they were admitted; the designated position was initiated soon after hospital admission and was maintained for 24 hours. The primary outcome was degree of disability at 90 days, as assessed with the use of the modified Rankin scale (scores range from 0 to 6, with higher scores indicating greater disability and a score of 6 indicating death). RESULTS: The median interval between the onset of stroke symptoms and the initiation of the assigned position was 14 hours (interquartile range, 5 to 35). Patients in the lying-flat group were less likely than patients in the sitting-up group to maintain the position for 24 hours (87% vs. 95%, P<0.001). In a proportional-odds model, there was no significant shift in the distribution of 90-day disability outcomes on the global modified Rankin scale between patients in the lying-flat group and patients in the sitting-up group (unadjusted odds ratio for a difference in the distribution of scores on the modified Rankin scale in the lying-flat group, 1.01; 95% confidence interval, 0.92 to 1.10; P=0.84). Mortality within 90 days was 7.3% among the patients in the lying-flat group and 7.4% among the patients in the sitting-up group (P=0.83). There were no significant between-group differences in the rates of serious adverse events, including pneumonia. CONCLUSIONS:Disability outcomes after acute stroke did not differ significantly between patients assigned to a lying-flat position for 24 hours and patients assigned to a sitting-up position with the head elevated to at least 30 degrees for 24 hours. (Funded by the National Health and Medical Research Council of Australia; HeadPoST ClinicalTrials.gov number, NCT02162017 .).
RCT Entities:
BACKGROUND: The role of supine positioning after acute stroke in improving cerebral blood flow and the countervailing risk of aspiration pneumonia have led to variation in head positioning in clinical practice. We wanted to determine whether outcomes in patients with acute ischemic stroke could be improved by positioning the patient to be lying flat (i.e., fully supine with the back horizontal and the face upwards) during treatment to increase cerebral perfusion. METHODS: In a pragmatic, cluster-randomized, crossover trial conducted in nine countries, we assigned 11,093 patients with acute stroke (85% of the strokes were ischemic) to receive care in either a lying-flat position or a sitting-up position with the head elevated to at least 30 degrees, according to the randomization assignment of the hospital to which they were admitted; the designated position was initiated soon after hospital admission and was maintained for 24 hours. The primary outcome was degree of disability at 90 days, as assessed with the use of the modified Rankin scale (scores range from 0 to 6, with higher scores indicating greater disability and a score of 6 indicating death). RESULTS: The median interval between the onset of stroke symptoms and the initiation of the assigned position was 14 hours (interquartile range, 5 to 35). Patients in the lying-flat group were less likely than patients in the sitting-up group to maintain the position for 24 hours (87% vs. 95%, P<0.001). In a proportional-odds model, there was no significant shift in the distribution of 90-day disability outcomes on the global modified Rankin scale between patients in the lying-flat group and patients in the sitting-up group (unadjusted odds ratio for a difference in the distribution of scores on the modified Rankin scale in the lying-flat group, 1.01; 95% confidence interval, 0.92 to 1.10; P=0.84). Mortality within 90 days was 7.3% among the patients in the lying-flat group and 7.4% among the patients in the sitting-up group (P=0.83). There were no significant between-group differences in the rates of serious adverse events, including pneumonia. CONCLUSIONS: Disability outcomes after acute stroke did not differ significantly between patients assigned to a lying-flat position for 24 hours and patients assigned to a sitting-up position with the head elevated to at least 30 degrees for 24 hours. (Funded by the National Health and Medical Research Council of Australia; HeadPoST ClinicalTrials.gov number, NCT02162017 .).
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