ENDOVASCULAR TREATMENT, Hypoxia-Ischemia, Brain, Stroke, Acute
Conditions
Brief summary
The overall incidence of good outcome for AIS following endovascular treatment is only proximately 50%. Whether NBO was safe and effective to improve acute ischemic stroke prognosis is still unclear. The investigators' hypothesis is thatNBO is a safe and effective strategy to improve longterm outcome in AIS patients undergoing endovascular treatment.
Detailed description
NBO therapy is to deliver high flow oxygen (10L/min) through an oxygen storage mask. This treatment should be started in the emergency room immediately after the patient is randomized into the group, and oxygen should be continued for 4 hours. In previous clinical studies of NBO, patients who have not receive revascularization often choose NBO for 8 hours, and studies have concluded that oxygen inhalation for more than 10 hours may bring about the risk of oxygen poisoning. However, a too short treatment time may not bring benefits. Secondly, ideally, we want to ensure that stroke patients receive NBO treatment before achieving reperfusion to protect the ischemic brain tissue, and add 1-2 hours after reperfusion. In the clinical environment after the patient arrives in the emergency department, it takes 2-3 hours to complete the revascularization process. Therefore, we believe that 4 hours of oxygen inhalation is reasonable. And our single-center study also supports that NBO treatment for 4 hours is beneficial. The specific content is as follows: In the emergency room, patients who are assessed for suspected large blood vessels of acute anterior circulation will be randomized after signing the informed consent. If the subject is randomly divided into NBO+ET group, by putting the patient on Oxygen mask, and then immediately give oxygen (10L/min). NBO treatment is no later than half an hour after randomization. Oxygen comes from the hospital's oxygen center and is transported through wall pipes (oxygen concentration: 100%). The oxygen mask and the wall oxygen are connected by a 1.5 meter long oxygen pipe. When the patient is transferred to the operating room, we provide oxygen through a portable oxygen cylinder (capacity: 4L). In addition, in the operating room and intensive care unit, patients continue to be given wall oxygen therapy until the oxygen inhalation lasts for 4 hours. The arterial blood gas was drawn after 4 hours of oxygen inhalation. The control group directly inhales room air through the patient's nasal cavity without using any equipment. At the same time, patients in the control group were also drawn blood gas analysis at corresponding time points (approximately 4 hours after randomization).
Interventions
OTHERoxygen
deliver high flow oxygen (10L/min)
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old. * The clinical symptoms and signs are consistent with acute anterior circulation large vessel occlusion; * NIHSS score ≥ 10 points; * (Level of consciousness) NIHSS score 0 or 1; * The time from onset to randomization is within 6 hours of onset; * The mRS score before stroke is 0-1; * The patient has good compliance and can complete the operation with local anesthesia; * The patient can cooperate with this study and follow-up in the future * Patient and family members sign informed consent。-
Exclusion criteria
* Rapid neurological function improvement, NIHSS score less than 10 points, or evidence of vessel recanalization prior to randomization; * Seizures at stroke onset; * Intracranial hemorrhage; * Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal; * Platelet count of less than 100,000 per cubic millimeter; * 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; * Life expectancy\<90 days; * Evidence of intracranial tumor;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale | 1 year ± 30 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 |
|---|---|---|
| The proportion of good prognosis | 1 year ± 30 days after randomization | 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 |
| Functional independence | 1 year ± 30 days after randomization | The Proportion of mRS 0-1 |
| The Proportion of mRS 0-3 | 1 year ± 30 days after randomization | secondary clinical efficacy endpoint |
| EuroQol- 5 Dimension (EQ-5D) | 1 year ± 30 days after randomization | EuroQol five dimensions questionnaire (EQ-5D)EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. |
| All-cause mortality | 1 year ± 30 days after randomization | clinical safety endpoint; |
| New major vascular events | 1 year ± 30 days after randomization | clinical safety endpoint; Major vascular events include fatal or nonfatal cardiac events, fatal or nonfatal stroke, or fatal or nonfatal major peripheral arterial or thrombo-embolic events. |
| kaplan-meier curve | 1 year ± 30 days after randomization | clinical efficacy endpoint |
| Barthel Index (BI) | 1 year ± 30 days after randomization | he BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis); |
Countries
China
Outcome results
None listed