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.
35-75 years
The symptoms and signs are consistent with acute anterior circulation ischemic stroke. The immediate postoperative angiographic recanalization grade was ≥ 2b.
Neurological deficit score at the time of enrollment: 5 ≤ NIHSS ≤ 15 points
Consciousness status (NIHSS 1a-1b items): 0-1 point
Subjects with HBO contraindications or intolerance
Postprocedural imaging identified either procedure-related subarachnoid hemorrhage or hemorrhagic transformation
Based on the medical history, it is suspected that the cerebral embolism is caused by sepsis or infective endocarditis
Expected lifespan < 90 days
Parallel
Hyperbaric Oxygen Therapy
Other intervention1.6 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 group
Other interventionConventional therapy
The 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.
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.
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.
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
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.
Click on the lead sponsor to view all of their trials.
