This article requires a subscription to view the full text. If you have a subscription you may use the login form below to view the article. Access to this article can also be purchased.
Abstract
Background and Objectives To investigate the safety and efficacy of normobaric hyperoxia (NBO) combined with endovascular treatment (EVT) in patients with acute ischemic stroke (AIS).
Methods In this single-center, proof-of-concept, assessor-blinded, randomized, controlled pilot study, patients with AIS in the acute anterior circulation with large vessel occlusion who had an indication for EVT were randomly assigned to the EVT group or the NBO + EVT group. The NBO + EVT group was given 100% oxygen through a face mask initiated before vascular recanalization (10L/min for 4 hours), while the EVT group was given room air. The primary endpoint was infarct volume measured by MRI within 24–48 hours after randomization.
Results A total of 231 patients were screened, and 86 patients were randomized into a ratio of 1:1 (EVT group, n = 43; NBO + EVT group, n = 43). The median infarction volume of the NBO + EVT group at 24–48 hours after randomization was significantly smaller than that of the EVT group (median 20.1 vs 37.7 mL, p < 0.01). The median mRS score at 90 days was 2 for the NBO + EVT group when compared with 3 for the EVT group (adjusted value 1.8, 95% CI 1.3–4.2; p = 0.038). Compared with the EVT group, the NBO + EVT group had a lower incidence of symptomatic intracranial hemorrhagic (7% vs 12%), mortality (9% vs 16%), and adverse events (33% vs 42%); however, such a difference was not statistically significant.
Discussion NBO in combination with EVT seems to be a safe and feasible treatment strategy that could significantly reduce infarct volume, improve short-term neurobehavioral test score, and enhance clinical outcomes at 90 days when compared with EVT alone in patients with AIS. These observations need to be further confirmed by a large, multicenter, randomized clinical trial.
Clinical Trials Registration NCT03620370.
Classification of Evidence This pilot study provides Class I evidence that NBO combined with standard EVT decreases infarction volume in patients with acute anterior circulation stroke.
GLOSSARY
- ADC=
- apparent diffusion coefficient;
- AIS=
- Acute ischemic stroke;
- ASITN/SIR=
- American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology;
- BBB=
- Blood-brain barrier;
- CTP=
- CT Perfusion;
- DWI=
- diffusion-weighted imaging;
- END=
- Early neurological deterioration;
- EVT=
- Endovascular therapy;
- ICH=
- Intracranial Hemorrhage;
- IQR=
- interquartile range;
- ITT=
- intention to treat;
- mRS=
- modified Rankin scale;
- mTICI=
- Modified Thrombolysis in Cerebral Infarction;
- NBO=
- Normobaric hyperoxia;
- NIHSS=
- NIH Stroke scale;
- pO2=
- pressure of oxygen;
- sICH=
- Symptomatic Intracranial Hemorrhage
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
↵* These authors contributed equally to this work.
Submitted and externally peer reviewed. The handling editor was José Merino, MD, MPhil, FAAN.
Class of Evidence NPub.org/coe
- Received October 31, 2021.
- Accepted in final form April 8, 2022.
- © 2022 American Academy of Neurology
AAN Members
We have changed the login procedure to improve access between AAN.com and the Neurology journals. If you are experiencing issues, please log out of AAN.com and clear history and cookies. (For instructions by browser, please click the instruction pages below). After clearing, choose preferred Journal and select login for AAN Members. You will be redirected to a login page where you can log in with your AAN ID number and password. When you are returned to the Journal, your name should appear at the top right of the page.
AAN Non-Member Subscribers
Purchase access
Letters: Rapid online correspondence
- Author Response: Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients: A Randomized Controlled Clinical Trial
- Author Response: Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients: A Randomized Controlled Clinical Trial
- Author Response: Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients: A Randomized Controlled Clinical Trial
- Author Response: Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients: A Randomized Controlled Clinical Trial
- Reader Response: Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients: A Randomized Controlled Clinical Trial
- Reader Response: Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients: A Randomized Controlled Clinical Trial
- Reader Response: Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients: A Randomized Controlled Clinical Trial
- Reader Response: Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients: A Randomized Controlled Clinical Trial
REQUIREMENTS
You must ensure that your Disclosures have been updated within the previous six months. Please go to our Submission Site to add or update your Disclosure information.
Your co-authors must send a completed Publishing Agreement Form to Neurology Staff (not necessary for the lead/corresponding author as the form below will suffice) before you upload your comment.
If you are responding to a comment that was written about an article you originally authored:
You (and co-authors) do not need to fill out forms or check disclosures as author forms are still valid
and apply to letter.
Submission specifications:
- Submissions must be < 200 words with < 5 references. Reference 1 must be the article on which you are commenting.
- Submissions should not have more than 5 authors. (Exception: original author replies can include all original authors of the article)
- Submit only on articles published within 6 months of issue date.
- Do not be redundant. Read any comments already posted on the article prior to submission.
- Submitted comments are subject to editing and editor review prior to posting.
