An interventional study of Normobaric oxygen therapy in Stroke, Acute, sponsored by Capital Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-07-19.
Sponsored by Capital Medical University · Not applicable, Interventional, and Treatment
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.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 86 is above the median of 50 across 5,482 interventional studies indexed under Stroke.
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Exclusion Criteria:
Normobaric oxygen therapy is the delivery of high-flow oxygen (10L/min) via oxygen storage facemask. This therapy should start in the pre-hospital or emergency room as soon as possible (within 1 hours) after diagnosis of ischemic stroke and last for 4 hours. All participant will receive mechanical thrombectomy and a standard clinical therapy.
Drug: Normobaric oxygen therapy
The participants receive mechanical thrombectomy therapy after diagnosed ischemic. All participants receive a standard clinical therapy.
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.
Cerebral infarct volume
Infarct volume is evaluated mainly through brain MRI(DWI)
Time frame: 24-48h after randomization
levels of blood biomarkers
Biomarkers for evaluation of BBB damage and brain injury:NSE、S100B、occludin、 claudin-5、MMP-9
Time frame: baseline; 24 ± 6 hours, 7 ± 2 days
modified Rankin Scale score (mRS)
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: 30 ± 5 days, 90 ± 10 days after randomization
The good prognosis at 90 days assessed by modified Rankin scale (mRS).
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: 90 ± 10 days after randomization
Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
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: 2 hours ± 15 minutes, 24 ± 6 hours, 7 ± 2 days, 30 ± 5 days after randomization ]
Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 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: from baseline to 24 ± 6 hours
Improvement of neurologic function after 24h
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: 24 ± 6 hours;
Barthel Index (BI)
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: 30 ± 5 days, 90 ± 10 days after randomization
Revascularization on 24-hour follow-up imaging
secondary imaging efficacy endpoint;
Time frame: 24 (12 to 36) hours;
24-hour neurologic deterioration;
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 ± 6 hours;
any intracranial hemorrhage on 24-hour follow-up imaging
imaging safety endpoints;per ECASS III definition and per Heidelberg bleeding classification
Time frame: 24 (12 to 36) hours
Symptomatic Intracerebral Hemorrhage
imaging safety endpoints;Deterioration in NIHSS score of ≥4 points within 24 hours;per ECASS III definition and per Heidelberg bleeding classification
Time frame: 24 (12 to 36) hours
Mortality and Stroke recurrence
clinical safety endpoint;
Time frame: 90 ± 10 days after randomization
Survival rates
secondary clinical efficacy endpoint;
Time frame: 7 ± 2 days, 90 ± 10 days after randomization
TICI (Thrombolysis in Cerebral Infarction perfusion scale grade)
secondary imaging efficacy endpoint;
Time frame: Time Frame: 4 hours ± 15 minutes
The infarct volume on 24-hour follow-up imaging
The infarct volume of cerebral infarct is evaluated by cranial CT;
Time frame: 24 (12 to 36) hours;
mRS4-6
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
Subgroup analysis of infarct volume
Stratify according to different risk factors：ASPECT; NIHSS; age;Ischemic penumbra volume; Site of occlusion; Time from stroke onset to randomization;Ischemic penumbra volume
Time frame: 24-48h after randomization
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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