Normobaric Hyperoxia Stabilizing Ischemic Penumbra
- Conditions
- Acute Ischemic Stroke
- Interventions
- Other: Oxygen 100%
- Registration Number
- NCT05781880
- Lead Sponsor
- Ji Xunming,MD,PhD
- Brief Summary
To investigate the safety and efficacy of normobaric hyperoxia (NBO) stabilizing penumbra in acute ischemic stroke patients.
- Detailed Description
All the enrolled patients were randomly assigned to NBO and control group. NBO group will be given 100% oxygen ( (10L/min for 4h) via a storage oxygen face mask and control group will be given oxygen using nasal oxygen(2L/min for 4h) .
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 78
Not provided
- Evidence of rapid improvement in neurological function and NIHSS score <6, or spontaneous recanalization before randomization
- The disease affecting assessment of baseline NIHSS score (dementia, epilepsy, neuromuscular disease, or psychiatric disease)
- Symptoms suggesting subarachnoid hemorrhage (even if CT scan is normal)
- Combined with the history, cerebral embolism due to sepsis or infective endocarditis was suspected
- Active or chronic obstructive pulmonary disease, pulmonary fibrosis, pneumonia, pleural effusion, acute respiratory distress syndrome, irregular breathing
- It is necessary to inhale (>3L/min) oxygen to maintain peripheral arterial oxygen saturation (SaO2>95%)
- Anemia or polycythemia vera or other conditions needing emergency oxygen patients
- Patients with upper gastrointestinal bleeding or nausea and vomiting can not complete inhalation oxygen using face mask
- Baseline blood glucose <2.78mmol/L or >22.2mmol/L
- Baseline platelet count <50×109/L
- Hereditary or acquired bleeding tendency, lack of coagulation factor, recent oral anticoagulant INR>3 or PPT more than 3 times
- Unstable vital signs (heart rate ≤50 beats/min or ≥120 beats/min, oxygen saturation ≤90%, R≥30 beats/min or ≤10 beats/min)
- Hypertension not controlled by medication: systolic blood pressure ≥185mmHg, or diastolic blood pressure ≥110mmHg
- Acute myocardial infarction suspected
- Pregnancy,
- Life expectancy <90 days
- Heart, liver and kidney failure
- Magnetic resonance contraindications
- Claustrophobia
- Allergic to contrast media
- Participating in other drug or device research
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Oxygen 100% Control group will be given nasal oxygen (2L/min for 4h）. All other therapy measures are the same as experimental group. NBO group Oxygen 100% Normobaric hyperoxia (NBO) oxygen group will be given 100% oxgen (10L/min for 4h) via a face mask.
- Primary Outcome Measures
Name Time Method changing of penumbra volume from baseline Day 0 the comparison of ratio of 4h following randomizing and baseline for penumbra volume between NBO and control group
- Secondary Outcome Measures
Name Time Method modified rankin scale (mRS) score at 90 days following randomizing Month 3 the mRS score comparison between NBO and control group; mRS score ranges from 0 to 5, and the higher score means a worse outcome.
Barthel Index at 90 days following randomizing Month 3 the comparison of Barthel Index between NBO and control group
EQ-5D index at 90 days following randomizing Month 3 the comparison of EQ-5D index between NBO and control group
National Institutes of Health Stroke Scale (NIHSS) score at 24h following randomizing Day 1 the comparison of NIHSS score between NBO and control group; NIHSS score ranges from 0 to 42, and higher scores mean a worse outcome.
BBB injured biomarkers at baseline and 24h following randomizing Day 1 the levels of BBB injured biomarkers comparison between NBO and control group
volume of core infarction at 4h following randomizing Day 0 core infarction volume comparison between NBO and control group
penumbra volume at 4h following randomizing Day 0 the absolute penumbra volume comparison between NBO and control group
volume of hypoperfusion region hypoperfusion at 4h following randomizing Day 0 the volume of hypoperfusion region hypoperfusion comparison between NBO and control group
Cerebral oxygen concentration at baseline and 4h following randomizing Day 0 the levels of cerebral oxygen comparison between NBO and control group
Trial Locations
- Locations (1)
Xuanwu Hospital of Capital Medical University
🇨🇳Beijing, Beijing, China