Endovascular Treatment, Neuroprotection, Stroke
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficiency of normobaric hyperoxia combined with endovascular treatment for acute ischemic stroke patients with stroke onset 6-24 hours.
Interventions
it is simple to administer via oxygen storage facemask at flow rates of 10 L/min for 4 hours.This therapy should begin in the emergency room as early as possible when patients meet the inclusion criteria and are randomized to the experimental group
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age≥18; * Suspected lage vessel occlusion of acute anterior circulation occlusion; i.e. either the ICA or the M1/M2-segment of the MCA; * Stroke symptom onset has been more than 6 hours but not more than 24 hours,and imaging confirmed the existenceof ischemic penumbra; * NIHSS score≥6; * Alberta Stroke Program Early CT score (ASPECTS) of 6-10 on non- contrast CT; * (Level of consciousness) NIHSS score of 0 or 1 * mRS score was 0-1 before stroke; * Informed consent obtained;
Exclusion criteria
* Rapid improvement in neurological status to an NIHSS \< 6 or evidence of vessel recanalization prior to randomization; * Seizures at stroke onset; * Intracranial hemorrhage; * Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg, or aggressive treatment intravenous medication)necessary to reduce blood pressure to these limits; * Symptoms rapidly improving; * Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal; * Platelet count of less than 100,000 per cubic millimeter; * CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere); * severe hepatic or renal dysfunction; * active and chronic obstructive pulmonary disease or acute respiratory distress syndrome; * \>3 L/min oxygen required to maintain peripheral arterial oxygen saturation (SaO2)#95% as per current stroke management guidelines; * medically unstable; * inability to obtain informed consent; * Life expectancy\<90 days; * Pregnant or breast-feeding women; * Unwilling to be followed up or poor compliance for treatment; * Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial; * Evidence of intracranial tumor; * Baseline blood glucose of \< 50 mg/dL (2.78 mmol) or \> 400 mg/dL (22.20 mmol); * Patients with upper gastrointestinal bleeding or nausea and vomiting who cannot use oxygen masks; * Other circumstances requiring emergency oxygen inhalation;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early neurologic improvement (ENI) at 24 hours | 24 ± 12 hours | ENI was defined as percent change NIHSS≥30%; Percent change NIHSS was defined as \[(admission NIHSS score-24-hour NIHSS score)x100/admission NIHSS score\]; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| modified Rankin Scale score (mRS) | 90 ± 14 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) |
| Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours | 24 ± 12 hours after randomization | 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) |
| Barthel Index (BI) | 90 ± 14 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); |
| Revascularization on 24-hour follow-up imaging | 24 ± 12 hours hours after randomization | secondary imaging efficacy endpoint;Successful recanalization was defined as mTICI 2b or 3 |
| Early neurologic deterioration | 24 ± 12 hours after randomization | 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; |
| Symptomatic Intracerebral Hemorrhage | 24± 12 hours hours after randomization | imaging safety endpoints;Deterioration in NIHSS score of ≥4 points within 24 hours;per ECASS III definition and per Heidelberg bleeding classification |
| National Institutes of Health Stroke Scale(NIHSS) Score | 4 hours ± 15 minutes, 24 ± 12 hours; 7 ± 2 days after randomization | the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits |
| Stroke recurrence | 90 ± 14 days，180 ± 30 days after randomization | clinical safety endpoint; |
| The 5-level EuroQol five dimensions questionnaire（EQ-5D-5L）score | 90 ± 14 days after randomization | secondary clinical efficacy endpoint, Quality of Life score; The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. |
| Delta NIHSS | 24 ± 12 hours after randomization | Delta NIHSS was defined (admission NIHSS score-24-hour NIHSS score). |
| Percent change NIHSS | 24 ± 12 hours after randomization | Percent change NIHSS was defined as \[(admission NIHSS score-24-hour NIHSS score)x100/admission NIHSS score\] |
| Cerebral infarct volume | 36 ± 12 hours after randomization | Infarct volume is evaluated mainly through brain MRI(DWI) or CT |
| Mortality | 90 ± 14 days after randomization | clinical safety endpoint; |
Countries
China
Outcome results
None listed