The Stroke Oxygen Pilot Study: A Randomized Controlled Trial of the Effects of Routine Oxygen Supplementation Early after Acute Stroke—Effect on Key Outcomes at Six Months
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{"title"=>"The Stroke Oxygen Pilot Study: A Randomized Controlled Trial of the Effects of Routine Oxygen Supplementation Early after Acute Stroke-Effect on Key Outcomes at Six Months", "type"=>"journal", "authors"=>[{"first_name"=>"Khalid", "last_name"=>"Ali", "scopus_author_id"=>"8556913000"}, {"first_name"=>"Anushka", "last_name"=>"Warusevitane", "scopus_author_id"=>"37862465000"}, {"first_name"=>"Frank", "last_name"=>"Lally", "scopus_author_id"=>"9241963800"}, {"first_name"=>"Julius", "last_name"=>"Sim", "scopus_author_id"=>"7202819265"}, {"first_name"=>"Sheila", "last_name"=>"Sills", "scopus_author_id"=>"22948731600"}, {"first_name"=>"Sarah", "last_name"=>"Pountain", "scopus_author_id"=>"36806899900"}, {"first_name"=>"Tracy", "last_name"=>"Nevatte", "scopus_author_id"=>"36773526100"}, {"first_name"=>"Martin", "last_name"=>"Allen", "scopus_author_id"=>"7404105628"}, {"first_name"=>"Christine", "last_name"=>"Roffe", "scopus_author_id"=>"6603757999"}], "year"=>2013, "source"=>"PLoS ONE", "identifiers"=>{"scopus"=>"2-s2.0-84878624689", "pui"=>"369060141", "sgr"=>"84878624689", "isbn"=>"1932-6203", "issn"=>"19326203", "pmid"=>"23755093", "doi"=>"10.1371/journal.pone.0059274"}, "id"=>"b6ee67bc-3f4c-3655-ada4-2f229258f586", "abstract"=>"INTRODUCTION: Post-stroke hypoxia is common, and may adversely affect outcome. We have recently shown that oxygen supplementation may improve early neurological recovery. Here, we report the six-month outcomes of this pilot study.\\n\\nMETHODS: Patients with a clinical diagnosis of acute stroke were randomized within 24 h of admission to oxygen supplementation at 2 or 3 L/min for 72 h or to control treatment (room air). Outcomes (see below) were assessed by postal questionnaire at 6 months. Analysis was by intention-to-treat, and statistical significance was set at p ≤ 0.05.\\n\\nRESULTS: Out of 301 patients randomized two refused/withdrew consent and 289 (148 in the oxygen and 141 in the control group) were included in the analysis: males 44%, 51%; mean (SD) age 73 (12), 71 (12); median (IQR) National Institutes of Health Stroke Scale score 6 (3, 10), 5 (3, 10) for the two groups respectively. At six months 22 (15%) patients in the oxygen group and 20 (14%) in the control group had died; mean survival in both groups was 162 days (p = 0.99). Median (IQR) scores for the primary outcome, the modified Rankin Scale, were 3 (1, 5) and 3 (1, 4) for the oxygen and control groups respectively. The covariate-adjusted odds ratio was 1.04 (95% CI 0.67, 1.60), indicating that the odds of a lower (i.e. better) score were non-significantly higher in the oxygen group (p = 0.86). The mean differences in the ability to perform basic (Barthel Index) and extended activities of daily living (NEADL), and quality of life (EuroQol) were also non-significant.\\n\\nCONCLUSIONS: None of the key outcomes differed at 6 months between the groups. Although not statistically significant and generally of small magnitude, the effects were predominantly in favour of the oxygen group; a larger trial, powered to show differences in longer-term functional outcomes, is now on-going.\\n\\nTRIAL REGISTRATION: Controlled-Trials.com ISRCTN12362720; Eudract.ema.europa.eu 2004-001866-41.", "link"=>"http://www.mendeley.com/research/stroke-oxygen-pilot-study-randomized-controlled-trial-effects-routine-oxygen-supplementation-early-a", "reader_count"=>21, "reader_count_by_academic_status"=>{"Professor > Associate Professor"=>2, "Researcher"=>5, "Student > Doctoral Student"=>3, "Student > Ph. D. Student"=>4, "Student > Postgraduate"=>3, "Other"=>1, "Student > Bachelor"=>2, "Lecturer"=>1}, "reader_count_by_user_role"=>{"Professor > Associate Professor"=>2, "Researcher"=>5, "Student > Doctoral Student"=>3, "Student > Ph. D. Student"=>4, "Student > Postgraduate"=>3, "Other"=>1, "Student > Bachelor"=>2, "Lecturer"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>1, "Medicine and Dentistry"=>14, "Agricultural and Biological Sciences"=>1, "Neuroscience"=>2, "Pharmacology, Toxicology and Pharmaceutical Science"=>1, "Psychology"=>2}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>14}, "Neuroscience"=>{"Neuroscience"=>2}, "Psychology"=>{"Psychology"=>2}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>1}, "Unspecified"=>{"Unspecified"=>1}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>1}}, "reader_count_by_country"=>{"United Kingdom"=>1}, "group_count"=>4}

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/1073339", "https://ndownloader.figshare.com/files/1073342"], "description"=>"<div><p>Introduction</p><p>Post-stroke hypoxia is common, and may adversely affect outcome. We have recently shown that oxygen supplementation may improve early neurological recovery. Here, we report the six-month outcomes of this pilot study.</p><p>Methods</p><p>Patients with a clinical diagnosis of acute stroke were randomized within 24 h of admission to oxygen supplementation at 2 or 3 L/min for 72 h or to control treatment (room air). Outcomes (see below) were assessed by postal questionnaire at 6 months. Analysis was by intention-to-treat, and statistical significance was set at <i>p</i>≤0.05.</p><p>Results</p><p>Out of 301 patients randomized two refused/withdrew consent and 289 (148 in the oxygen and 141 in the control group) were included in the analysis: males 44%, 51%; mean (SD) age 73 (12), 71 (12); median (IQR) National Institutes of Health Stroke Scale score 6 (3, 10), 5 (3, 10) for the two groups respectively. At six months 22 (15%) patients in the oxygen group and 20 (14%) in the control group had died; mean survival in both groups was 162 days (<i>p</i> = 0.99). Median (IQR) scores for the primary outcome, the modified Rankin Scale, were 3 (1, 5) and 3 (1, 4) for the oxygen and control groups respectively. The covariate-adjusted odds ratio was 1.04 (95% CI 0.67, 1.60), indicating that the odds of a lower (i.e. better) score were non-significantly higher in the oxygen group (<i>p</i> = 0.86). The mean differences in the ability to perform basic (Barthel Index) and extended activities of daily living (NEADL), and quality of life (EuroQol) were also non-significant.</p><p>Conclusions</p><p>None of the key outcomes differed at 6 months between the groups. Although not statistically significant and generally of small magnitude, the effects were predominantly in favour of the oxygen group; a larger trial, powered to show differences in longer-term functional outcomes, is now on-going.</p><p>Trial Registration</p><p>Controlled-Trials.com <a href=\"http://www.controlled-trials.com/ISRCTN12362720\" target=\"_blank\">ISRCTN12362720</a>; Eudract.ema.europa.eu <a href=\"https://eudract.ema.europa.eu/2004-001866-41\" target=\"_blank\">2004-001866-41</a></p></div>", "links"=>[], "tags"=>["cardiovascular", "stroke", "Clinical research design", "clinical trials", "geriatrics", "rehabilitation", "neurology", "Cerebrovascular diseases", "Ischemic stroke", "Non-clinical medicine", "Health care policy", "Quality of life", "randomized", "controlled", "supplementation", "acute", "outcomes"], "article_id"=>710800, "categories"=>["Medicine"], "users"=>["Khalid Ali", "Anushka Warusevitane", "Frank Lally", "Julius Sim", "Sheila Sills", "Sarah Pountain", "Tracy Nevatte", "Martin Allen", "Christine Roffe"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0059274.s001", "https://dx.doi.org/10.1371/journal.pone.0059274.s002"], "stats"=>{"downloads"=>0, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_The_Stroke_Oxygen_Pilot_Study_A_Randomized_Controlled_Trial_of_the_Effects_of_Routine_Oxygen_Supplementation_Early_after_Acute_Stroke_8212_Effect_on_Key_Outcomes_at_Six_Months_/710800", "title"=>"The Stroke Oxygen Pilot Study: A Randomized Controlled Trial of the Effects of Routine Oxygen Supplementation Early after Acute Stroke—Effect on Key Outcomes at Six Months", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2013-06-03 00:13:20"}

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Relative Metric

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