1. The goal of this clinical trial is to evaluate the efficacy and safety of hyperbaric oxygen (HBO)in stroke patients after endovascular treatment 2. The main questions it aims to answer is: Whether HBO can improve the prognosis of ischemic stroke patients after endovascular treatment? 3. Participants will: receive HBO (1.6 Atmosphere Absolute,1.6ATA),Once a day, for 1 hour each time, for 5 days a week (it can be non-consecutive days), the total course of treatment is 10 times. undergo three scheduled face to face or telephone follow-up assessments during the 12-month period following HBO.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
424
1.6 atmosphere absolute (1.6 ATA), HBO treatment administrated via mask or hood, one 60 minutes session, once daily, 5 days a week (can be non consecutive days), with a total of 10 sessions.
Conventional therapy
Emergency Intensive Care Unit
Beijing, Beijing Municipality, China
RECRUITINGBeijing Chaoyang Hospital, Capital Medical University
Beijing, China
NOT_YET_RECRUITINGThe proportion of patients with a favorable prognosis (mRS score of 0-2 ) after randomization at 90 (±7) days
Modified Rankin Scale (mRS) is defined as the gold standard for measuring global functional outcomes after stroke: 0-1 indicating functional independence, 0-2 favorable prognosis, defining functional independence, 4-5 Severely disabled, 6 death. Higher mRS scores indicate worse prognosis.
Time frame: Day 90 (±7) post-randomization
Core infarction volume on Diffusion-Weighted Imaging
The effectiveness of HBO for patients with acute ischemic stroke was evaluated based on the core cerebral infarction volume.
Time frame: Day 10 (±1)post-randomization
National Institutes of Health Stroke Scale (NIHSS)score [(0, Normal)-(42, worst)]
The effectiveness of HBO therapy in patients with acute ischemic stroke undergoing endovascular treatment was evaluated based on the improvement rate of NIHSS score day 10 post-randomization.
Time frame: Day 10(±1) NIHSS score post-randomization
mRS score [ (0, Normal)-(6, worst)]
To assess the effectiveness of HBO treament for ischemic stroke using mRS score on day 10, 30, 90 and 360 post-randomization
Time frame: Day 10 (±1)post-randomization; Day 30(±3) post-randomization; Day 180(±14) post-randomization; Day 360(±30) post-randomization.
Distribution of mRS score [(0, normal)-6(worst)]
mRS (0-1): the proportion of functional independence; mRS (0-2): the proportion of good prognosis; mRS (4-6) : the proportion of severe disability.
Time frame: Day 90 (±7) post-randomization
Bartherl index (BI)[(0, worst)-(100, normal)]
Functional independence was assessed using the BI
Time frame: Day 30(±3), 90(±7) , 180(±14) and 360 (±30) post-randomization
EuroQol 5-Dimensions(EQ-5D)[(0, worst)-(100, normal)]
Health-related quality of life was measured using EQ-5D.
Time frame: Day 30(±3), 90(±7), 180(±14), 360(±30) post-randomization
Stroke recurrence rate
New symptoms persisting for \> 24 hours and new lension on the DWI.
Time frame: Day 30(±3) , 90(±7d), 180(±14d) and 360(±30) post-randomization
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