Xuanwu hospital;Capital Medical University
Beijin, China
NCT Number: NCT03620370
NBO is a nonpharmacological measure of neuroprotection. The purpose of our study is to evaluate the safety and efficiency of NBO(Normobaric hyperoxia) in the acute ischemic stroke patients who received endovascular treatment. Looking for more clinical evidence for the ischemic stroke patients who will be treated with NBO in the future.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Beijin, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In this study, it is simple to administer via oxygen storage facemask at flow rates of 10 L/min for 4 hours. This therapy start should in Pre-hospital or emergency room as early as possible after diagnosed ischemic stroke and uninterrupted during other treatments including mechanical thrombolytic therapy and standard clinical treatment.
Time frame: 24-48h after randomization
Infarct volume is evaluated mainly through brain MRI(DWI)
Time frame: baseline; 24 ± 6 hours, 7 ± 2 days
Biomarkers for evaluation of BBB damage and brain injury:NSE、S100B、occludin、 claudin-5、MMP-9
Time frame: 30 ± 5 days, 90 ± 10 days after randomization
secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death)
Time frame: 90 ± 10 days after randomization
secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death);The ratio of 0 to 2;
Time frame: 2 hours ± 15 minutes, 24 ± 6 hours, 7 ± 2 days, 30 ± 5 days after randomization ]
secondary clinical efficacy endpoint; the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits
Time frame: from baseline to 24 ± 6 hours
secondary clinical efficacy endpoint;the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits)
Time frame: 24 ± 6 hours;
NIHSS score decreased by more than 4 points or NIHSS score was 0;secondary clinical efficacy endpoint;the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits)
Time frame: 30 ± 5 days, 90 ± 10 days after randomization
secondary clinical efficacy endpoint;the BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis);
Time frame: 24 (12 to 36) hours;
secondary imaging efficacy endpoint;
Time frame: 24 ± 6 hours;
NIHSS score increased by more than 4 points);the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits);clinical safety endpoint;
Time frame: 24 (12 to 36) hours
imaging safety endpoints;per ECASS III definition and per Heidelberg bleeding classification
Time frame: 24 (12 to 36) hours
imaging safety endpoints;Deterioration in NIHSS score of ≥4 points within 24 hours;per ECASS III definition and per Heidelberg bleeding classification
Time frame: 90 ± 10 days after randomization
clinical safety endpoint;
Time frame: 7 ± 2 days, 90 ± 10 days after randomization
secondary clinical efficacy endpoint;
Time frame: Time Frame: 4 hours ± 15 minutes
secondary imaging efficacy endpoint;
Time frame: 24 (12 to 36) hours;
The infarct volume of cerebral infarct is evaluated by cranial CT;
Time frame: 90 ± 10 days after randomization
secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death)
Time frame: 24-48h after randomization
Stratify according to different risk factors:ASPECT; NIHSS; age;Ischemic penumbra volume; Site of occlusion; Time from stroke onset to randomization;Ischemic penumbra volume
Capital Medical University
Other
The Safety and Efficacy of Normobaric Hyperoxia Combined With Reperfusion for Acute Ischemic Stroke:A Randomized, Controlled Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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