The purpose of this study is to determine the long-term efficacy and safety of Normobaric Hyperoxia combined with intravenous thrombolysis for acute ischemic stroke.
In this study, cases of acute ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The Normobaric Hyperoxia(NBO) group receive basic intravenous thrombolysis and given 100% oxygen inhalation at a ventilation rate of 10L/ min using a sealed non-ventilating oxygen storage mask and keep giving oxygen for 4 hours. The control group receive basic intravenous thrombolysis and given oxygen inhalation at a ventilation rate of 1L/min using nasal cannula and keep giving oxygen for 4 hours. The investigators aimed to determine the long-term effect of Normobaric Hyperoxia combined with intravenous thrombolysis for acute ischemic stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,230
Within 4.5 hours after stroke onset, patients were randomized into the NBO group and immediately given 100% oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 10L/ min using a sealed non-ventilating oxygen storage mask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain ventilation, the FiO2 should be set to 1.0.
For nasal oxygen group, Patients were immediately given oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 1L/min using nasal cannula and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain, the FiO2 should be set to 0.3 and gradualy incerased if spO2≤94%.
Xuan Wu Hospital,Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGUtility-weighted modified Rankin scale scores
Utility-weighted modified Rankin scale scores
Time frame: 12 months±14 days after randomization
Cerebral infarct volume
The infarct volume of cerebral infarct is evaluated by MRI
Time frame: 24-48hours after randomization
modified Rankin Scale (mRS) score
Ordinal distribution of mRS at 12 months±14 days after randomization; mRS score ranges from 0 to 5, and the higher score means a worse outcome
Time frame: 12 months±14 days after randomization
Good functional outcome
Proportion of subjects with modified rankin scale (mRS) 0-2 at 12 months±14 days after randomization
Time frame: 12 months±14 days after randomization
Excellent functional outcome
Proportion of subjects with modified Rankin Scale (mRS) 0-1 at 6 months±14 days after randomization; mRS score ranges from 0 to 5, and the higher score means a worse outcome
Time frame: 6 months±14 days after randomization
Good functional outcome
Proportion of subjects with modified rankin scale (mRS) 0-2 at 6 months±14 days after randomization
Time frame: 6 months±14 days after randomization
modified Rankin Scale (mRS) score
Ordinal distribution of mRS at 6 months±14 days after randomization; mRS score ranges from 0 to 5, and the higher score means a worse outcome
Time frame: 6 months±14 days after randomization
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10% dose of rt-PA (0.9 mg/kg) is given as bolus and the rest given as an infusion over the remaining 1 hour. Maximum dose 90mg.
Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits
Time frame: 4 ± 2 hours, 24 ± 6 hours, 72 ± 24 hours, 7 ± 2 days after randomization
Barthel Index (BI)
The BI is an ordinal disability score of 10 categories (range from 0 to 100, higher values indicate better prognosis)
Time frame: 6 months±14 days,12 months±14 days after randomization
EuroQol five dimensions questionnaire(EQ-5D)
The score ranges from 0 to 100, with higher scores indicating optimal health
Time frame: 6 months±14 days,12 months±14 days after randomization
Stroke-related mortality
Safety endpoint; the proportion of stroke related deaths in each group
Time frame: 12 months±14 days after randomization
All-cause mortality
Safety endpoint; the proportion of all patients who died in each group
Time frame: 12 months±14 days after randomization
Symptomatic intracranial hemorrhage
Proportion of subjects with symptomatic intracranial hemorrhage at 24 ± 6 hours after randomization (defined by ECASSII and ECASS III)
Time frame: 24 ± 6 hours after randomization
Asymptomatic intracranial hemorrhage
The incidence of asymptomatic intracranial hemorrhage at 24 ± 6 hours after randomization
Time frame: 24 ± 6 hours after randomization
PH2 intracranial hemorrhage
The incidence of PH2 intracranial hemorrhage at 24 ± 6 hours after randomization (according to SITS standards)
Time frame: 24 ± 6 hours after randomization
Adverse events/serious adverse events
Safety endpoint; the proportion of adverse events/serious adverse events in each group
Time frame: 24 ± 12 hours, 7 ± 2 days, 90± 7 days, 6 months±14 days,12 months±14 days after randomization
Excellent functional outcome
Proportion of subjects with modified Rankin Scale (mRS) 0-1 at 12 months±14 days after randomization; mRS score ranges from 0 to 5, and the higher score means a worse outcome
Time frame: 12 months±14 days after randomization