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NCT Number: NCT07049692

Hyperbaric Oxygen After Stroke Thrombectomy: A Multicenter Randomized Trial on Safety and Efficacy

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.

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Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Intensive Care Unit, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Pre-stroke functional status (mRS score): 0-1
  • Time from surgery to randomization grouping: ≤ 72 hours
  • Patient or legal representative who signed the informed consent form
  • Preoperative CT angiography or magnetic resonance angiography confirmed large vessel occlusion (internal carotid artery or middle cerebral artery M1 segment) that was consistent with the symptoms and signs; And the area supplied by the middle cerebral artery in the brain is less than 1/3.
  • A lberta S troke P rogram E arly C T S core ≥ 6

Exclusion criteria

  • 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
  • Severe heart, liver and kidneys failure
  • Pregnancy
  • Hereditary or acquired bleeding tendency, deficiency of coagulation factors, recent use of oral anticoagulants with an international normalized ratio (INR) > 3 or activated partial thromboplastin time (APTT) exceeding the normal value by more than 3 times
  • Baseline platelet count < 50×10 9/L
  • Baseline blood glucose is less than 2.78 mmol/L or greater than 22.2 mmol/L.
  • Unstable vital signs (heart rate ≤ 50 beats/min or ≥ 120 beats/min, oxygen saturation ≤ 90%, respiration ≥ 30 breaths/min or ≤ 10 breaths/min);
  • Hypertension that cannot be controlled by medication: Systolic blood pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg;
  • Suspected of having acute myocardial infarction;
  • Currently involving in the research of other projects related to drugs or medical devices.
  • CT or MRI scans revealed intracranial tumors (except for cerebellar meningiomas) and intracranial arteriovenous malformations.
  • Based on the medical history and CT or MRI findings, a diagnosis of internal carotid artery dissection or aortic dissection is suspected;
  • Based on the medical history and CT or MRI findings, cerebral vasculitis is suspected.
  • Based on the clinical evidence of multiple vascular regions being occluded (either in the bilateral anterior circulation or anterior/posterior circulation) or bilateral infarction or multi-region infarction as detected by CT angiography or magnetic resonance angiography;
  • CT or magnetic resonance imaging shows a significant midline shift effect (> 0.5 cm);
  • CT angiography or magnetic resonance angiography confirmed the presence of cerebral vasculitis or cerebral vasculitis syndrome;

Treatment and study plan

Hyperbaric Oxygen Therapy

Other

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 group

Other

Conventional therapy

Primary outcomes

  1. The proportion of patients with a favorable prognosis (mRS score of 0-2 ) after randomization at 90 (±7) days

    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.

Secondary outcomes

  1. Core infarction volume on Diffusion-Weighted Imaging

    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.

  2. National Institutes of Health Stroke Scale (NIHSS)score [(0, Normal)-(42, worst)]

    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.

  3. mRS score [ (0, Normal)-(6, worst)]

    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

  4. Distribution of mRS score [(0, normal)-6(worst)]

    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.

  5. Bartherl index (BI)[(0, worst)-(100, normal)]

    Time frame: Day 30(±3), 90(±7) , 180(±14) and 360 (±30) post-randomization

    Functional independence was assessed using the BI

  6. EuroQol 5-Dimensions(EQ-5D)[(0, worst)-(100, normal)]

    Time frame: Day 30(±3), 90(±7), 180(±14), 360(±30) post-randomization

    Health-related quality of life was measured using EQ-5D.

  7. Stroke recurrence rate

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shuyuan Yuan

CONTACT

[email protected]

+86 18511703665

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 3, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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