The purpose of this RCT trial is to evaluate whether the sequential hyperbaric oxygen therapy can improve the 90-day functional outcome in patients with acute large vessel occlusion ischemic stroke after endovascular treatment.
This is a multicenter, prospective, open-label, endpoint-blinded, randomized controlled trial with a 1:1 ratio, comparing the effect of hyperbaric oxygen therapy plus standard medical treatment versus standard medical treatment alone after endovascular treatment in patients with acute large vessel occlusion ischemic stroke. The primary outcome is modified Rankin Scale (mRS) score distribution at 90 days (±14 days) after randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
420
The first treatment was initiated within 24 hours after enrollment. The treatment plan is: in a medical multi-person air pressurized chamber, the treatment pressure is 0.2 MPa, the pressurization time is 30 minutes, the mask inhales 100% oxygen for 60 minutes, and the decompression time is 30 minutes. Once a day, once on the 1st, 2nd, and 3rd days after enrollment (i.e., within the 24-hour, 48-hour, and 72-hour time window), a total of 3 times. Vital signs such as blood pressure, heart rate, and blood oxygen saturation will be monitored before, during, and after each hyperbaric oxygen therapy. The rest of the treatment is standard medical treatment and monitoring according to the current clinical guideline "2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke: A Guideline From the American Heart Association/American Stroke Association" "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023".
According to the current guideline "2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke: A Guideline From the American Heart Association/American Stroke Association" "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023", they receive standard medical treatment and monitoring (including antithrombotic drugs, lipid-lowering drugs, blood pressure management, etc.), not entering the hyperbaric oxygen chamber for treatment.
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
RECRUITINGmRS score distribution at 90 days
Modified Rankin Scale (mRS) score distribution at 90 days (±14 days) after randomization
Time frame: 90±14 days after randomization
mRS score 0-1 at 90 days after randomization
Time frame: 90±14 days after randomization
mRS score 0-2 at 90 days after randomization
Time frame: 90±14 days after randomization
Change in NIHSS score from baseline to 24 hours postoperatively
Time frame: 24 hours after endovascular treatment
Change in NIHSS score from baseline to 5 days postoperatively (after the end of hyperbaric oxygen therapy)
Time frame: 5 days after endovascular treatment
Recanalization rate of responsible arteries at 24-48h postoperatively
Time frame: 24-48 hours after endovascular treatment
Volume of cerebral infarction on the 5th postoperative day or at discharge (after the end of hyperbaric oxygen therapy)
assessed by MRI or CT
Time frame: 5 days after endovascular treatment or at discharge
Total number of days in hospital
Number of days hospitalized (from randomization to hospital discharge)
Time frame: From date of randomization until date of hospital discharge, assessed up to 30 days.
Quality of life EQ-5D-5L score at 90 days after randomization
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The EuroQoL 5-Dimensions 5-Level (EQ-5D-5L) is a five-dimension, five-level health-related quality of life instrument. Based on the Chinese value set, its utility score ranges from -0.391 to 1.000, with higher scores indicating better outcomes.
Time frame: 90±14 days after randomization
mRS score 0-1 at 1 year after randomization
Time frame: 1 year ±30 days after randomization
mRS score 0-2 at 1 year after randomization
Time frame: 1 year ±30 days after randomization