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
| Autor: | Sarah Pountain, Khalid Ali, Martin W. Allen, Anushka Warusevitane, Frank Lally, Tracy Nevatte, Sheila Sills, Christine Roffe, Julius Sim |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Male
Activities of daily living Time Factors Non-Clinical Medicine lcsh:Medicine Pilot Projects Cardiovascular law.invention Randomized controlled trial Modified Rankin Scale law Surveys and Questionnaires Activities of Daily Living lcsh:Science Multidisciplinary Rehabilitation RC666 Stroke Treatment Outcome Neurology Medicine Female medicine.symptom Research Article medicine.medical_specialty Clinical Research Design Cerebrovascular Diseases Odds Memory Statistical significance Internal medicine medicine Humans Clinical Trials Survival analysis Aged Ischemic Stroke Health Care Policy business.industry lcsh:R Odds ratio Hypoxia (medical) RC0952 Survival Analysis Oxygen Geriatrics Physical therapy Quality of Life lcsh:Q business |
| Zdroj: | PLoS ONE, Vol 8, Iss 6, p e59274 (2014) PLoS ONE |
| ISSN: | 1932-6203 |
| Popis: | 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.\ud \ud 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.\ud \ud 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.\ud \ud 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.\ud \ud Trial Registration: Controlled-Trials.com ISRCTN12362720; Eudract.ema.europa.eu 2004-001866-41 |
| Databáze: | OpenAIRE |
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