Evidence map›Paper›PMID 23755093›Full record

Trial reportPloS one2014

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.

Khalid Ali, Anushka Warusevitane, Frank Lally, Julius Sim, Sheila Sills, Sarah Pountain, Tracy Nevatte, Martin Allen, Christine Roffe

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Normobaric Hyperoxia Therapy in Treating Stroke.Clinical interventions in aging · 2025
    Review
  9. Review
  10. Review
  11. Article
  12. Oxygen Treatment in Intensive Care and Emergency Medicine.Deutsches Arzteblatt international · 2018
    Review
  13. Review
  14. Review
  15. Hypoxia after stroke: a review of experimental and clinical evidence.Experimental & translational stroke medicine · 2016
    Review
  16. Article
  17. Review
  18. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Khalid AliAcademic Department of Geriatrics, Brighton and Sussex Medical School, Brighton, United Kingdom.
Anushka Warusevitane
Frank Lally
Julius Sim
Sheila Sills
Sarah Pountain
Tracy Nevatte
Martin Allen
Christine Roffe

Funding

Department of Health PB-PG-0407-11433
6 · The paper itself

Abstract

introductionPost-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.

methodsPatients 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.

resultsOut 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.

conclusionsNone 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 registrationControlled-Trials.com ISRCTN12362720; Eudract.ema.europa.eu 2004-001866-41.

Indexed as

Activities of Daily LivingAgedFemaleHumansMaleMemoryOxygenPilot ProjectsQuality of LifeStrokeSurveys and QuestionnairesSurvival AnalysisTime FactorsTreatment OutcomeOxygen

Identifiers

PMID23755093
PMCPMC3670882

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.