Hyperbaric Oxygen Therapy
Other1.6 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.
NCT Number: NCT07049692
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.
Interested in participating?
Request Info35 year–75 year
All sexes
Interventional
Not applicable
Emergency Intensive Care Unit, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Day 90 (±7) post-randomization
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 10 (±1)post-randomization
The effectiveness of HBO for patients with acute ischemic stroke was evaluated based on the core cerebral infarction volume.
Time frame: Day 10(±1) NIHSS score post-randomization
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)post-randomization; Day 30(±3) post-randomization; Day 180(±14) post-randomization; Day 360(±30) post-randomization.
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 90 (±7) post-randomization
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 30(±3), 90(±7) , 180(±14) and 360 (±30) post-randomization
Functional independence was assessed using the BI
Time frame: Day 30(±3), 90(±7), 180(±14), 360(±30) post-randomization
Health-related quality of life was measured using EQ-5D.
Time frame: Day 30(±3) , 90(±7d), 180(±14d) and 360(±30) post-randomization
New symptoms persisting for > 24 hours and new lension on the DWI.
Contact information is provided by the study sponsor or research team.
Beijing Chao Yang Hospital
Other
Evaluation of the Efficacy and Safety of Hyperbaric Oxygen in Patients After Endovascular Treatment for Acute Ischemic Stroke: A Multicenter, Open-label, Randomized Controlled Clinical Trial
Acronym: NOTICE-1
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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