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Safety and Efficacy of Endovascular Treatment Combined with Early Hyperbaric Oxygen Therapy for Large Vessel Occlusive Stroke

The effect and mechanism of early combined use of hyperbaric oxygen therapy for vascular recanalization on large vessel occlusive stroke in high-altitude areas

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085608
Enrollment
Unknown
Registered
2024-06-13
Start date
2023-02-04
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ischaemic stroke

Interventions

Hyperbaric Oxygen Therapy + Endovascular Treatment:Participants will enter the medical hyperbaric oxygen chamber on the 3rd to 5th day after revascularization treatment. Under the pressure of 2.0 ATA,
Sham Control:Participants will enter the medical hyperbaric chamber for oxygen therapy 3 to 5 days after revascularization. Under a pressure of 1.2 ATA, 21% oxygen will be inhaled through a mask for 6

Sponsors

Ya'an People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Age = 18 years old; (2) Time from onset to randomization within 24 hours; (3) First acute ischemic stroke confirmed by CT or MRI; (4) NIHSS score ranging from 5 to 25 at onset; (5) ASPECTS score = 5; (6) Large artery occlusion confirmed by cerebral angiography, including internal carotid artery, M1/M2 segment of middle cerebral artery, A1 segment of anterior cerebral artery, P1 segment of posterior cerebral artery, vertebral artery, or basilar artery; (7) Endovascular treatment within 24 hours of onset, including retrievable stent thrombectomy, intra-arterial thrombolysis, catheter aspiration, balloon dilation, stent placement, or combined use of the above methods as recommended by current guidelines; (8) Post-operative mTICI grade reaching 2b or 3; (9) The patient or their family member has signed a written informed consent form.

Exclusion criteria

Exclusion criteria: (1) History of previous stroke; (2) Pre-onset mRS score = 2; (3) Intracranial hemorrhage or subarachnoid hemorrhage confirmed by CT or MRI; (4) Pregnant or lactating women; (5) History of previous oxygen poisoning; (6) Patients with severe dysfunction of vital organs such as heart, lung, liver, and kidney; (7) Inability to withdraw intravenous pumping drugs after 5 days of expected endovascular treatment, or unstable vital signs after withdrawal; (8) Currently participating in other clinical trials; (9) Expected lifespan < 6 months; (10) Contraindications for hyperbaric oxygen therapy, mainly including: 1) Untreated pneumothorax or mediastinal emphysema; 2) Severe emphysema, pulmonary bulla, or bronchiectasis; 3) Second-degree or higher atrioventricular block; 4) Diabetic patients with unstable blood sugar control; 5) Angle-closure glaucoma; 6) Concurrent use of disulfiram (excluding disulfiram-like reactions caused by cephalosporins and other drugs); 7) Concurrent use of antineoplastic drugs such as bleomycin, cisplatin, or doxorubicin; 8) Active internal bleeding and hemorrhagic diseases; 9) History of oxygen poisoning; 10) Tubercular cavities; 11) Unstable vital signs such as temperature, pulse, respiration, or blood pressure; 12) Severe sinusitis; 13) Hypercapnia; 14) Retinal detachment; 15) Claustrophobia; 16) Uncontrolled epilepsy.

Design outcomes

Primary

MeasureTime frame
Functional Independence;Intracranial Hemorrhage;

Secondary

MeasureTime frame
All-cause Mortality;NIHSS;Symptomatic intracranial hemorrhage;Any adverse reactions related to pressurized air therapy;

Countries

China

Contacts

Public ContactJian Wang

Ya'an People's Hospital

wangjian0724@126.com+86 135 5006 4528

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026