Stroke, Acute, Neuroprotection
Conditions
Keywords
Normobaric hyperoxia, Endovascular treatment, Acute ischemic stroke
Brief summary
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.
Interventions
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.
DRUGSham Normobaric Hyperoxia
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%；
PROCEDUREEndovascular Thrombectomy
EVT is the international guidelines for the treatment of acute ischemic stroke with lage vessel occlusion.
Sponsors
Tianjin Huanhu Hospital
Shengli Oilfield Hospital
Beijing Fengtai You'anmen Hospital
Jiujiang University Affiliated Hospital
Zhangzhou Municipal Hospital of Fujian Province
Baotou Central Hospital
Luoyang Central Hospital
Nanyang Central Hospital
Qingdao Central Hospital
The Third People's Hospital of Jinan
Rizhao People's Hospital
Anyang People's Hospital
Shanghai 10th People's Hospital
Dalian Municipal Central Hospital
Zhoukou Central Hospital
Nanshi Hospital of Nanyang
The second Nanning People's Hospital
Zhumadian Central Hospital
Taizhou Hospital
Second Affiliated Hospital of Nanchang University
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
General inclusion criteria 1. It conforms to the indications for endovascular thrombectomy 2. 18 ≦ Age ≦ 80 years old. 3. The clinical symptoms and signs are consistent with acute anterior circulation large vessel occlusion; 10≤NIHSS≤20； 4. (Level of consciousness) NIHSS score 0 or 1; 5. The time from onset to randomization is within 6 hours of onset; 6. The mRS score before stroke is 0-1; 7. Patient and family members sign informed consent. Image 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale (mRS) score | 90 ± 14 days after randomization | the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scores assessed by National Institutes of Health Stroke Scale(NIHSS) | 24 ± 6 hours, 72 ± 24 hours, 7 ± 2 days after randomization | Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits |
| The proportion of neurological function improvement | 24 ± 6 hours after randomization | ≥ 4 point reduction in NIHSS score from baseline |
| Cerebral infarct volume | 24-48h after randomization | The infarct volume of cerebral infarct is evaluated by MRI or CT |
| The proportion of good prognosis | 90 ± 14 days after randomization | defined by mRS 0-2 |
| The proportion of functional independence | 90 ± 14 days after randomization | defined by mRS 0-1 |
| The proportion of severe disability | 90 ± 14 days after randomization | defined by mRS 4-6 |
| Vessel recanalization | 24 ± 6 hours after randomization | 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 |
| Arterial oxygen partial pressure | after 4 hours of oxygen therapy | Laboratory indicators, obtained by arterial blood gas analysis |
| Barthel Index (BI) | 90 ± 14 days after randomization | the BI is an ordinal disability score of 10 categories (range from 0 to 100, higher values indicate better prognosis) |
| EuroQol five dimensions questionnaire（EQ-5D） | 90 ± 14 days after randomization | The score ranges from 0 to 100, with higher scores indicating optimal health |
| Days of hospitalization | 90 ± 14 days after randomization | Length of stay in hospital |
| All-cause mortality | 90 ± 14 days after randomization | Safety endpoint; the proportion of all patients who died in each group |
| Serious adverse events | 90 ± 14 days after randomization | Safety endpoint; the proportion of serious adverse events in each group |
| Successful vessel recanalization | Immediately after procedure | 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 |
| Oxygen-related adverse events | 90 ± 14 days after randomization | 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 |
| Adverse events of special interest | 90 ± 14 days after randomization | Safety endpoint; the proportion of adverse events of special interest in each group, including malignant brain edema, perioperative myocardial infarction, and acute heart failure |
| Symptomatic intracranial hemorrhage | 24 ± 6 hours after randomization | Safety endpoint; according to ECASS II definition |
| Any intracranial hemorrhage | 24 ± 6 hours after randomization | Safety endpoint; the proportion of any intracranial hemorrhage in each group |
| Early neurological deterioration (END) | 24 ± 6 hours after randomization | Safety endpoint; defined as ≥4 point increase in NIHSS score from baseline |
| Systolic and diastolic blood pressure | 24 ± 6 hours after randomization | Safety endpoint; vital signs |
| Heart rate | 24 ± 6 hours after randomization | Safety endpoint; vital signs |
| Respiratory rate | 24 ± 6 hours after randomization | Safety endpoint; vital signs |
| Oxygen saturation | 24 ± 6 hours after randomization | Safety endpoint; vital signs |
| PH of arterial blood gas analysis | after 4 hours of oxygen therapy | Safety endpoint |
| PaCO2 of arterial blood gas analysis | after 4 hours of oxygen therapy | Safety endpoint |
| Lactic acid of arterial blood gas analysis | after 4 hours of oxygen therapy | Safety endpoint |
| Stroke-related mortality | 90 ± 14 days after randomization | Safety endpoint; the proportion of stroke related deaths in each group |
Countries
China
Outcome results
None listed