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| Name | Class |
|---|---|
| Tianjin Huanhu Hospital | OTHER |
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Normoxia Hyperoxia (NBO) is a neuroprotective approach that can be implemented early. NBO is simple and non-invasive and can be used at home or in an ambulance to ensure the shortest possible time after cerebral ischemia occurs. The previous study by the investigators suggested that NBO therapy in the early stage of cerebral ischemia has a neuroprotective effect on ischemic brain injury. Although the neuroprotective effect of NBO has been demonstrated, the optimal duration of treatment for NBO to exert neuroprotective effect is still unclear. Therefore, further discussion of the duration of NBO treatment will contribute to the clinical application of NBO and provide a definite theoretical basis for the treatment of cerebral infarction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low flow oxygen group | Placebo Comparator | patients were randomized into the Low flow oxygen group and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 1L/ min using a oxygen storage mask and keep giving oxygen for 4 hours. |
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| NBO group (2h) | Experimental | patients were randomized into the NBO group (2h) and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 10L/ min using a oxygen storage mask and keep giving oxygen for 2 hours. |
|
| NBO group (4h) | Experimental | patients were randomized into the NBO group (4h) and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 10L/ min using a oxygen storage mask and keep giving oxygen for 4 hours. |
|
| NBO group (6h) | Experimental | patients were randomized into the NBO group (6h) and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 10L/ min using a oxygen storage mask and keep giving oxygen for 6 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normobaric Hyperoxia (NBO) | Other | NBO was inhaled as early as possible before revascularization, and inhaled for 1h/2h/4h according to different groups |
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| Measure | Description | Time Frame |
|---|---|---|
| Cerebral infarct volume | The infarct volume is evaluated by MRI or CT scan | Within 72 hours after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Scores assessed by National Institutes of Health Stroke Scale(NIHSS) | secondary clinical efficacy endpoint; the NIHSS is a stroke severity score composed of 11 items (range from 0 to 41, higher values indicate more severe deficits) | 24hours, 72hours, day7 after randomization |
| The proportion of good prognosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Huanhu Hospital | Tianjin | Tianjin Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38747162 | Derived | Li W, Wang S, Liu L, Chen J, Lan J, Ding J, Chen Z, Yuan S, Qi Z, Wei M, Ji X. Normobaric Hyperoxia Combined With Endovascular Treatment Based on Temporal Gradient: A Dose-Escalation Study. Stroke. 2024 Jun;55(6):1468-1476. doi: 10.1161/STROKEAHA.123.046106. Epub 2024 May 15. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Low flow oxygen | Other | immediately given oxygen inhalation at a ventilation rate of 1L/ min using a oxygen storage mask and keep giving oxygen for 4 hours. |
|
the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death;with higher scores indicating more severe disability);The ratio of 0 to 2; |
| 90 ± 10 days after randomization |
| neurological function improvement rate | 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); | Time Frame: 24 ± 6 hours |
| modified Rankin Scale score (mRS) score | secondary clinical efficacy endpoint; the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability,and 6=death) | 30 ± 7 days, 90 ± 10 days after randomization; |
| Vascular recanalization rate | secondary imaging efficacy endpoint; Extended Treatment In Cerebral Ischemia (eTICI);The eTICI is an ordinal hierarchical scale ranging from 0 to 3, with higher scores indicating better antegrade reperfusion of the previously occluded target artery ischemic territory; eTICI 2B or 3 are defined as successful recanalization; | Time Frame: 4 hours ± 15 minutes |
| blood biomarkers : occludin(ng/ml), MMP-9(ng/ml), S100B(ng/ml),NSE(ng/ml),GFAP(ng/ml),PGP9.5(ng/ml),etc | Biomarkers for evaluation of BBB damage , brain injury and inflammation,etc: | 24 ± 6 hours, 72 ± 24 hours |
| Incidence of oxygen-related adverse events | Including Headache, dizziness, nausea, vomiting, chest tightness, shortness of breath, cough,etc; | 24 ± 6 hours, |
| Incidence of 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; | 24 ± 6 hours; |
| Incidence of 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 | 24± 12 hours hours after randomization |
| Incidence of any intracranial hemorrhage | imaging safety endpoints;per ECASS III definition and per Heidelberg bleeding classification | 24± 12 hours hours after randomization |
| all-cause death rate | clinical safety endpoint; Ratio of total deaths from all causes to all enrollments | 90 ± 10 days after randomization |
| Incidence of adverse events | clinical safety endpoint; | 90 ± 10 days after randomization |
| Incidence of surgery-related complications | clinical safety endpoint; | 24± 12 hours hours after randomization |
| stroke related death rate | clinical safety endpoint; Stroke-related deaths as a proportion of all participants | 90 ± 10 days after randomization; |
| Vital signs:respiration(times/min) | clinical safety endpoint; | 0 hours, 2 hours, 4 hours after randomization; |
| Vital signs:heart rate: (times/min) | clinical safety endpoint; | 0 hours, 2 hours, 4 hours after randomization; |
| Vital signs:blood pressure(mmHg) | clinical safety endpoint; | 0 hours, 2 hours, 4 hours after randomization; |
| Vital signs:oxygen saturation (%) | clinical safety endpoint; | 0 hours, 2 hours, 4 hours after randomization; |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |