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.
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.(That is an incorrect statement you blithering idiots)
Trial Registration
ISRCTN Identifier:
ISRCTN52416964
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