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| Name | Class |
|---|---|
| Tianjin Huanhu Hospital | OTHER |
| Shengli Oilfield Hospital | OTHER |
| Beijing Fengtai You'anmen Hospital | UNKNOWN |
| Jiujiang University Affiliated Hospital |
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The current endovascular treatment has increased the recanalization rate to more than 90%. Even so, the prognosis rate of stroke is still less than 50%. Our previous research confirmed that the neuroprotective effect of Normobaric Hyperoxia (NBO) from multiple perspectives. However, the clinical study on NBO was not satisfactory, which might be due to the absence of vascular recanalization therapy. Therefore, The investigators conducted this RCT study to further explore the Efficacy and safety of NBO combined with endovascular treatment in patients with acute ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBO group | Experimental | Normobaric Hyperoxia combined with endovascular mechanical thrombectomy |
|
| Control group | Placebo Comparator | Inhale air placebo plus endovascular mechanical thrombectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normobaric Hyperoxia | Drug | Within 6 hours after stroke onset, patients were randomized into the NBO group and immediately given 100% oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 10L/ min using a sealed non-ventilating oxygen storage mask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain ventilation, the FiO2 should be set to 1.0. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale (mRS) score | the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death) | 90 ± 14 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral infarct volume | The infarct volume of cerebral infarct is evaluated by MRI or CT | 24-48h after randomization |
| The proportion of good prognosis | defined by mRS 0-2 |
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Inclusion Criteria:
General inclusion criteria
1. Preoperative CT or MR or DSA angiography found large vessel occlusion (internal carotid artery or middle cerebral artery M1 segment) that were consistent with symptoms and signs; 2. ASPECT score ≥ 6 points 3. <1/3 MCA area involvement (confirmed by CT or MRI)
Exclusion Criteria:
General exclusion criteria
Image exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Xunming Ji, MD,PhD | Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuan Wu Hospital,Capital Medical University | Beijing | Beijing Municipality | 100069 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39922675 | Derived | Li W, Lan J, Wei M, Liu L, Hou C, Qi Z, Li C, Jiao L, Yang Q, Chen W, Liu S, Yue X, Dong Q, Yuan H, Gao Z, Wu X, Wen C, Li T, Jiang C, Li D, Chen Z, Shi J, Shi W, Yuan J, Qin Y, Li B, Fisher M, Feng W, Liu KJ, Ji X; OPENS-2 Investigators. Normobaric hyperoxia combined with endovascular treatment for acute ischaemic stroke in China (OPENS-2 trial): a multicentre, randomised, single-blind, sham-controlled trial. Lancet. 2025 Feb 8;405(10477):486-497. doi: 10.1016/S0140-6736(24)02809-5. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| OTHER_GOV |
| Zhangzhou Municipal Hospital of Fujian Province | OTHER |
| Baotou Central Hospital | OTHER |
| Luoyang Central Hospital | OTHER |
| Nanyang Central Hospital | OTHER |
| Qingdao Central Hospital | OTHER |
| The Third People's Hospital of Jinan | UNKNOWN |
| Rizhao People's Hospital | OTHER |
| Anyang People's Hospital | UNKNOWN |
| Shanghai 10th People's Hospital | OTHER |
| Dalian Municipal Central Hospital | OTHER |
| Zhoukou Central Hospital | OTHER |
| Nanshi Hospital of Nanyang | UNKNOWN |
| The second Nanning People's Hospital | UNKNOWN |
| Zhumadian Central Hospital | OTHER |
| Taizhou Hospital | OTHER |
| Second Affiliated Hospital of Nanchang University | OTHER |
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| Sham Normobaric Hyperoxia | Drug | For Sham NBO group, Patients were immediately given oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 1l/min using the same mask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain, the FiO2 should be set to 0.3 and gradualy incerased if spO2≤94%; |
|
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| Endovascular Thrombectomy | Procedure | EVT is the international guidelines for the treatment of acute ischemic stroke with lage vessel occlusion. |
|
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| 90 ± 14 days after randomization |
| The proportion of functional independence | defined by mRS 0-1 | 90 ± 14 days after randomization |
| The proportion of severe disability | defined by mRS 4-6 | 90 ± 14 days after randomization |
| Scores assessed by National Institutes of Health Stroke Scale(NIHSS) | Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits | 24 ± 6 hours, 72 ± 24 hours, 7 ± 2 days after randomization |
| The proportion of neurological function improvement | ≥ 4 point reduction in NIHSS score from baseline | 24 ± 6 hours after randomization |
| Successful vessel recanalization | Successful vessel recanalization is defined by eTICI 2b/2c/3 on final angiogram. Extended treatment in cerebral ischaemia (eTICI) score range from 0 to 3, with higher scores indicating better reperfusion | Immediately after procedure |
| Vessel recanalization | Vessel recanalization is evaluated by CTA or MRA and assessed by AOL grades. Arterial Occlusive Lesion (AOL) range from 0 to 3, with higher scores indicating better recanalization | 24 ± 6 hours after randomization |
| Arterial oxygen partial pressure | Laboratory indicators, obtained by arterial blood gas analysis | after 4 hours of oxygen therapy |
| Barthel Index (BI) | the BI is an ordinal disability score of 10 categories (range from 0 to 100, higher values indicate better prognosis) | 90 ± 14 days after randomization |
| EuroQol five dimensions questionnaire(EQ-5D) | The score ranges from 0 to 100, with higher scores indicating optimal health | 90 ± 14 days after randomization |
| Days of hospitalization | Length of stay in hospital | 90 ± 14 days after randomization |
| All-cause mortality | Safety endpoint; the proportion of all patients who died in each group | 90 ± 14 days after randomization |
| Serious adverse events | Safety endpoint; the proportion of serious adverse events in each group | 90 ± 14 days after randomization |
| Stroke-related mortality | Safety endpoint; the proportion of stroke related deaths in each group | 90 ± 14 days after randomization |
| Oxygen-related adverse events | Safety endpoint; the proportion of oxygen-related adverse events in each group, including severe lung infection, pneumothorax, atelectasis, respiratory failure, acute respiratory distress syndrome, and cardiopulmonary arrest | 90 ± 14 days after randomization |
| Adverse events of special interest | Safety endpoint; the proportion of adverse events of special interest in each group, including malignant brain edema, perioperative myocardial infarction, and acute heart failure | 90 ± 14 days after randomization |
| Symptomatic intracranial hemorrhage | Safety endpoint; according to ECASS II definition | 24 ± 6 hours after randomization |
| Any intracranial hemorrhage | Safety endpoint; the proportion of any intracranial hemorrhage in each group | 24 ± 6 hours after randomization |
| Early neurological deterioration (END) | Safety endpoint; defined as ≥4 point increase in NIHSS score from baseline | 24 ± 6 hours after randomization |
| Systolic and diastolic blood pressure | Safety endpoint; vital signs | 24 ± 6 hours after randomization |
| Heart rate | Safety endpoint; vital signs | 24 ± 6 hours after randomization |
| Respiratory rate | Safety endpoint; vital signs | 24 ± 6 hours after randomization |
| Oxygen saturation | Safety endpoint; vital signs | 24 ± 6 hours after randomization |
| PH of arterial blood gas analysis | Safety endpoint | after 4 hours of oxygen therapy |
| PaCO2 of arterial blood gas analysis | Safety endpoint | after 4 hours of oxygen therapy |
| Lactic acid of arterial blood gas analysis | Safety endpoint | after 4 hours of oxygen therapy |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |