Clinical trial NCT05781880: Normobaric Hyperoxia Stabilizing Ischemic Penumbra
Official title: Efficiency and Safety Evaluation of Normobaric Hyperoxia Stabilizing the Penumbra in Patients With Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: Normobaric Hyperoxia
Acute ischemic stroke
penumbra
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) .

Eligibility criteria: Inclusion criteria:

* Age≥18岁
* The signs and symptoms are consistent with anterior circulation infarction, and baseline NIHSS score：6-20
* Level of consciousness on admission：0-1
* mRS score before stroke: 0-1
* Patients who did not receive revascularization therapy
* The time from onset (finally normal) to randomization is less than 24h
* Patients who signed informed consent
* CTA or MRA confirmed internal carotid artery occlusion or M1/M2 segment occlusion of middle cerebral artery
* The low-perfusion area with Tmax\>6s was larger than the core infarction, and the mismatch ratio was greater than or equal to 1.8.

Exclusion Criteria:

* 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

Primary outcomes:
measure: changing of penumbra volume from baseline
timeFrame: Day 0
Secondary outcomes:
measure: penumbra volume at 4h following randomizing
timeFrame: Day 0
measure: volume of core infarction at 4h following randomizing
timeFrame: Day 0
measure: volume of hypoperfusion region hypoperfusion at 4h following randomizing
timeFrame: Day 0
measure: National Institutes of Health Stroke Scale (NIHSS) score at 24h following randomizing
timeFrame: Day 1
measure: modified rankin scale (mRS) score at 90 days following randomizing
timeFrame: Month 3
measure: Barthel Index at 90 days following randomizing
timeFrame: Month 3
measure: EQ-5D index at 90 days following randomizing
timeFrame: Month 3
measure: BBB injured biomarkers at baseline and 24h following randomizing
timeFrame: Day 1
measure: Cerebral oxygen concentration at baseline and 4h following randomizing
timeFrame: Day 0
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital of Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital of Capital Medical University
name: Xunming Ji, MD
role: PRINCIPAL_INVESTIGATOR
References: