The Stroke Oxygen Study SO2S - a multi-center study to assess whether routine oxygen treatment in the first 72 hours after a stroke improves long-term outcome: study protocol for a randomized controlled trialReportar como inadecuado




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Trials

, 15:99

First Online: 31 March 2014Received: 23 October 2013Accepted: 13 March 2014DOI: 10.1186-1745-6215-15-99

Cite this article as: Roffe, C., Nevatte, T., Crome, P. et al. Trials 2014 15: 99. doi:10.1186-1745-6215-15-99

Abstract

BackgroundMild hypoxia is common in stroke patients and may have significant adverse effects on the ischemic brain after stroke. The use of oxygen treatment is rapidly increasing in European stroke units but is not without side effects. It impedes early mobilization, could pose an infection risk, and may encourage the formation of toxic free radicals, leading to further damage to the ischemic brain. In the Stroke Oxygen Pilot Study 2 or 3 L-min for 72 hours neurological recovery at one week was better in the oxygen group than in controls, and after correction for difference in baseline stroke severity and prognostic factors, there was a trend to better outcome with oxygen at six months. Oxygen was as effective in mild as in severe strokes.

Oxygen saturation is lower at night than during the day, and episodes of oxygen desaturation are common during sleep. Nocturnal oxygen supplementation is likely to reduce the burden of hypoxia without interfering with daytime mobilization and rehabilitation.

Before wider use of oxygen supplementation becomes established it is important to obtain better evidence on which patients benefit from such treatment.

MethodsParticipants will be randomized to one of three groups: the first will receive continuous oxygen for 72 hours at a rate of 2 or 3 L-min depending on baseline oxygen saturation, the second group will receive nocturnal oxygen only at a rate of 2 or 3 L-min depending on baseline oxygen saturation and the third group will not receive any oxygen control. A baseline assessment is performed at randomization and a one-week follow-up completed. Outcome data at three, six and twelve months will be obtained via a questionnaire sent to the patient by the trial center.

DiscussionThis study will provide evidence on the effectiveness of oxygen supplementation for the treatment of stroke and whether nocturnal oxygen is a potentially beneficial therapy regimen.

Trial registrationThis trial is registered with the ISRCTN register ID number ISRCTN52416964

KeywordsStroke Oxygen supplementation Oxygen Hypoxia Oximetry Oxygen saturation AbbreviationsADLActivities of Daily Living

ATPAdenosine triphosphate

DMSCData monitoring and safety committee

EQ-5DTMEuroQoL quality of life

GCSGlasgow Coma Scale

MRCMedical Research Council

NEADLNottingham Extended Activities of Daily Living

NIHSSNational Institutes of Health Stroke Scale

SO2SThe Stroke Oxygen Study

SSVsix simple variables

SUSARSuspected unexpected serious adverse reaction

TMCTrial Management Committee

TSCTrial Steering Committee

WHOWorld Health Organization.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-99 contains supplementary material, which is available to authorized users.

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Autor: Christine Roffe - Tracy Nevatte - Peter Crome - Richard Gray - Julius Sim - Sarah Pountain - Linda Handy - Peter Handy

Fuente: https://link.springer.com/







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