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Original Investigation
September 26, 2017

Effect of Routine Low-Dose Oxygen Supplementation on Death and Disability in Adults With Acute StrokeThe Stroke Oxygen Study Randomized Clinical Trial

Christine Roffe, MD1,2; Tracy Nevatte, PhD2,3; Julius Sim, PhD2; et al Jon Bishop, PhD4; Natalie Ives, MSc4; Phillip Ferdinand, MRCP1; Richard Gray, MSc4,5; for the Stroke Oxygen Study Investigators and the Stroke OxygenStudy Collaborative Group
Author Affiliations
  • 1University Hospital of North Midlands NHS Trust, Stoke-on-Trent, United Kingdom
  • 2Faculty of Medicine and Health Sciences, Keele University, Staffordshire, United Kingdom
  • 3Directorate for Engagement & Partnerships, Keele University, Staffordshire, United Kingdom
  • 4Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom
  • 5MRC Population Health Research Unit, University of Oxford, Oxford, United Kingdom
JAMA. 2017;318(12):1125-1135. doi:10.1001/jama.2017.11463
Key Points

Question  Does routine prophylactic low-dose oxygen supplementation after acute stroke improve functional outcome?

Findings  In this randomized clinical trial, 8003 patients with acute stroke were randomized within 24 hours of admission to 3 days of continuous oxygen, nocturnal oxygen, or control. After 3 months, there was no significant difference in death and disability for the combined oxygen groups compared with control (odds ratio, 0.97) or for the continuous oxygen group compared with the nocturnal oxygen group (odds ratio, 1.03).

Meaning  Routine low-dose oxygen did not improve outcomes in nonhypoxic patients after acute stroke.

Abstract

Importance  Hypoxia is common in the first few days after acute stroke, is frequently intermittent, and is often undetected. Oxygen supplementation could prevent hypoxia and secondary neurological deterioration and thus has the potential to improve recovery.

Objective  To assess whether routine prophylactic low-dose oxygen therapy was more effective than control oxygen administration in reducing death and disability at 90 days, and if so, whether oxygen given at night only, when hypoxia is most frequent, and oxygen administration is least likely to interfere with rehabilitation, was more effective than continuous supplementation.

Design, Setting, and Participants  In this single-blind randomized clinical trial, 8003 adults with acute stroke were enrolled from 136 participating centers in the United Kingdom within 24 hours of hospital admission if they had no clear indications for or contraindications to oxygen treatment (first patient enrolled April 24, 2008; last follow-up January 27, 2015).

Interventions  Participants were randomized 1:1:1 to continuous oxygen for 72 hours (n = 2668), nocturnal oxygen (21:00 to 07:00 hours) for 3 nights (n = 2667), or control (oxygen only if clinically indicated; n = 2668). Oxygen was given via nasal tubes at 3 L/min if baseline oxygen saturation was 93% or less and at 2 L/min if oxygen saturation was greater than 93%.

Main Outcomes and Measures  The primary outcome was reported using the modified Rankin Scale score (disability range, 0 [no symptoms] to 6 [death]; minimum clinically important difference, 1 point), assessed at 90 days by postal questionnaire (participant aware, assessor blinded). The modified Rankin Scale score was analyzed by ordinal logistic regression, which yields a common odds ratio (OR) for a change from one disability level to the next better (lower) level; OR greater than 1.00 indicates improvement.

Results  A total of 8003 patients (4398 (55%) men; mean [SD] age, 72 [13] years; median National Institutes of Health Stroke Scale score, 5; mean baseline oxygen saturation, 96.6%) were enrolled. The primary outcome was available for 7677 (96%) participants. The unadjusted OR for a better outcome (calculated via ordinal logistic regression) was 0.97 (95% CI, 0.89 to 1.05; P = .47) for oxygen vs control, and the OR was 1.03 (95% CI, 0.93 to 1.13; P = .61) for continuous vs nocturnal oxygen. No subgroup could be identified that benefited from oxygen. At least 1 serious adverse event occurred in 348 (13.0%) participants in the continuous oxygen group, 294 (11.0%) in the nocturnal group, and 322 (12.1%) in the control group. No significant harms were identified.

Conclusions and Relevance  Among nonhypoxic patients with acute stroke, the prophylactic use of low-dose oxygen supplementation did not reduce death or disability at 3 months. These findings do not support low-dose oxygen in this setting.

Trial Registration  ISRCTN Identifier: ISRCTN52416964

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