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

Sim, J; Bishop, J; Gray, R; and the Stroke Oxygen Study Collaborative Group, Stroke Oxygen Study Investigators; Roffe, C; Nevatte, T; Ives, N; Ferdinand, P

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


Authors

J Bishop

R Gray

Stroke Oxygen Study Investigators and the Stroke Oxygen Study Collaborative Group

T Nevatte

N Ives

P Ferdinand



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.

Journal Article Type Article
Acceptance Date Sep 26, 2017
Publication Date Sep 26, 2017
Publicly Available Date Mar 29, 2024
Journal JAMA
Print ISSN 0098-7484
Publisher American Medical Association
Peer Reviewed Peer Reviewed
Volume 318
Issue 12
Pages 1125 - 1135
DOI https://doi.org/10.1001/jama.2017.11463
Keywords Acute Disease, Adult, Aged, Disability Evaluation, Female, Humans, Hypoxia, Logistic Models, Male, Middle Aged, Oxygen, Oxygen Inhalation Therapy, Single-Blind Method, Stroke, Treatment Outcome
Publisher URL https://jamanetwork.com/journals/jama/article-abstract/2654819?redirect=true

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