Treatment Duration on Normobaric Hyperoxia in Acute Ischemic Stroke
- Conditions
- Stroke, AcuteNeuroprotectionEndovascular Treatment
- Interventions
- Other: Normobaric Hyperoxia (NBO)Other: Low flow oxygen
- Registration Number
- NCT05404373
- Lead Sponsor
- Capital Medical University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Symptoms and signs were consistent with acute anterior circulation stroke,
- NIHSS score≥6分;Alberta Stroke Program Early CT score (ASPECTS)≥6;
- Met the indications for endovascular therapy;
- (Level of consciousness)NIHSS score 0 or 1; MRS score was 0-1 before stroke
- The time from onset to randomization was within 24 hours;
- Preoperative CTA or MRA confirmed the presence of large vessel occlusion (internal carotid artery or middle cerebral artery M1, M2 segments);
- Patients and their families signed informed consent
- 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;
- Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with INR > 3.0 or PTT > 3 times normal;
- Platelet count of less than 100,000 per cubic millimeter;
- Severe hepatic or renal dysfunction;
- Severe, sustained hypertension (Systolic Blood Pressure >185 mmHg or Diastolic Blood Pressure >110 mmHg)
- Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol) 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;
- Patients who could not complete the 90-day follow-up;
- Evidence of intracranial tumor;
- Patients with anemia or polycythemia vera or other situations that require urgent oxygen inhalation;
- Patients with upper gastrointestinal bleeding or nausea or vomiting so that they cannot cooperate with the mask to inhale oxygen.
- A history of severe allergies to contrast agents;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NBO group (2h) Normobaric Hyperoxia (NBO) 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. Low flow oxygen group Low flow oxygen 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. NBO group (4h) Normobaric Hyperoxia (NBO) 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) Normobaric Hyperoxia (NBO) 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.
- Primary Outcome Measures
Name Time Method Cerebral infarct volume Within 72 hours after randomization The infarct volume is evaluated by MRI or CT scan
- Secondary Outcome Measures
Name Time Method Scores assessed by National Institutes of Health Stroke Scale(NIHSS) 24hours, 72hours, day7 after randomization 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)
neurological function improvement rate Time Frame: 24 ± 6 hours 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);
Incidence of any intracranial hemorrhage 24± 12 hours hours after randomization imaging safety endpoints;per ECASS III definition and per Heidelberg bleeding classification
Vital signs:heart rate: (times/min) 0 hours, 2 hours, 4 hours after randomization; clinical safety endpoint;
Incidence of oxygen-related adverse events 24 ± 6 hours, Including Headache, dizziness, nausea, vomiting, chest tightness, shortness of breath, cough,etc;
blood biomarkers : occludin(ng/ml), MMP-9(ng/ml), S100B(ng/ml),NSE(ng/ml),GFAP(ng/ml),PGP9.5(ng/ml),etc 24 ± 6 hours, 72 ± 24 hours Biomarkers for evaluation of BBB damage , brain injury and inflammation,etc:
all-cause death rate 90 ± 10 days after randomization clinical safety endpoint; Ratio of total deaths from all causes to all enrollments
Incidence of adverse events 90 ± 10 days after randomization clinical safety endpoint;
Incidence of surgery-related complications 24± 12 hours hours after randomization clinical safety endpoint;
Vital signs:blood pressure(mmHg) 0 hours, 2 hours, 4 hours after randomization; clinical safety endpoint;
Vital signs:oxygen saturation (%) 0 hours, 2 hours, 4 hours after randomization; clinical safety endpoint;
The proportion of good prognosis 90 ± 10 days after randomization 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;
modified Rankin Scale score (mRS) score 30 ± 7 days, 90 ± 10 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)
Vascular recanalization rate Time Frame: 4 hours ± 15 minutes 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;
Incidence of 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
stroke related death rate 90 ± 10 days after randomization; clinical safety endpoint; Stroke-related deaths as a proportion of all participants
Vital signs:respiration(times/min) 0 hours, 2 hours, 4 hours after randomization; clinical safety endpoint;
Incidence of neurologic deterioration; 24 ± 6 hours; 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;
Trial Locations
- Locations (1)
Tianjin Huanhu Hospital
🇨🇳Tianjin, Tianjin, China