Khalid Ali
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
Ali, Khalid; Warusevitane, Anushka; Lally, Frank; Sim, Julius; Sills, Sheila; Pountain, Sarah; Nevatte, Tracy; Allen, Martin; Roffe, Christine
Authors
Anushka Warusevitane
Frank Lally
Julius Sim j.sim@keele.ac.uk
Sheila Sills
Sarah Pountain
Tracy Nevatte
Martin Allen
Christine Roffe c.roffe@keele.ac.uk
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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN12362720; Eudract.ema.europa.eu 2004-001866-41.
Acceptance Date | Feb 12, 2013 |
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Online Publication Date | Jun 3, 2013 |
Publication Date | Jun 3, 2013 |
Publicly Available Date | Mar 29, 2024 |
Journal | PLoS One |
Print ISSN | 1932-6203 |
Publisher | Public Library of Science |
Peer Reviewed | Peer Reviewed |
Volume | 8 |
Issue | 6 |
Article Number | e59274 |
DOI | https://doi.org/10.1371/journal.pone.0059274 |
Keywords | Activities of Daily Living, Aged, Female, Humans, Male, Memory, Oxygen, Pilot Projects, Quality of Life, Stroke, Surveys and Questionnaires, Survival Analysis, Time Factors, Treatment Outcome |
Publisher URL | http://dx.doi.org/10.1371/journal.pone.0059274 |
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