To investigate the safety and efficacy of normobaric hyperoxia (NBO) stabilizing penumbra in acute ischemic stroke patients.
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) .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
78
NBO therapy were given 100% oxygen via a face mask (10L/min for 4h)
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGchanging of penumbra volume from baseline
the comparison of ratio of 4h following randomizing and baseline for penumbra volume between NBO and control group
Time frame: Day 0
penumbra volume at 4h following randomizing
the absolute penumbra volume comparison between NBO and control group
Time frame: Day 0
volume of core infarction at 4h following randomizing
core infarction volume comparison between NBO and control group
Time frame: Day 0
volume of hypoperfusion region hypoperfusion at 4h following randomizing
the volume of hypoperfusion region hypoperfusion comparison between NBO and control group
Time frame: Day 0
National Institutes of Health Stroke Scale (NIHSS) score at 24h following randomizing
the comparison of NIHSS score between NBO and control group; NIHSS score ranges from 0 to 42, and higher scores mean a worse outcome.
Time frame: Day 1
modified rankin scale (mRS) score at 90 days following randomizing
the mRS score comparison between NBO and control group; mRS score ranges from 0 to 5, and the higher score means a worse outcome.
Time frame: Month 3
Barthel Index at 90 days following randomizing
the comparison of Barthel Index between NBO and control group
Time frame: Month 3
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EQ-5D index at 90 days following randomizing
the comparison of EQ-5D index between NBO and control group
Time frame: Month 3
BBB injured biomarkers at baseline and 24h following randomizing
the levels of BBB injured biomarkers comparison between NBO and control group
Time frame: Day 1
Cerebral oxygen concentration at baseline and 4h following randomizing
the levels of cerebral oxygen comparison between NBO and control group
Time frame: Day 0