RecruitingNCT07049692NOTICE-1Updated Jul 24, 2026

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

An interventional study of Hyperbaric Oxygen Therapy and Conventional therapy group in Acute Ischemic Stroke, sponsored by Beijing Chao Yang Hospital. Recruiting at 2 sites in China. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by Beijing Chao Yang Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

Started Jul 2026; still recruiting 2 months later.

Phase: Not applicable
Study type: Interventional
Enrollment: 424
Allocation: Randomized
Ages: 35 Years to 75 Years
Sex: All

Study summary

The goal of this clinical trial is to evaluate the efficacy and safety of hyperbaric oxygen (HBO)in stroke patients after endovascular treatment
The main questions it aims to answer is:
Whether HBO can improve the prognosis of ischemic stroke patients after endovascular treatment?
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.

Conditions studied

Acute Ischemic Stroke

Browse trials for

Ischemic Stroke 2,593

Keywords

HBO
acute ischemic stroke
endovascular treatment

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's planned enrollment of 424 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Beijing Chao Yang Hospital is the lead sponsor of 135 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 35 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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;

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 424 participants (estimated)

Study arms

Experimental
hyperbaric oxygen therapy
Other: Hyperbaric Oxygen Therapy
Other
Control group
Other: Conventional therapy group

Interventions

OtherHyperbaric Oxygen Therapy
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.
OtherConventional therapy group
Conventional therapy

What researchers measure

Primary outcomes

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.
Time frame: Day 90 (±7) post-randomization

Secondary outcomes

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.
Time frame: Day 10 (±1）post-randomization
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.
Time frame: Day 10(±1) NIHSS score 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
Time frame: Day 10 (±1）post-randomization; Day 30(±3) post-randomization; Day 180(±14) post-randomization; Day 360(±30) 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.
Time frame: Day 90 (±7) post-randomization
Bartherl index (BI)[(0, worst)-(100, normal)]
Functional independence was assessed using the BI
Time frame: Day 30(±3), 90(±7) , 180(±14) and 360 (±30) post-randomization
EuroQol 5-Dimensions(EQ-5D)[(0, worst)-(100, normal)]
Health-related quality of life was measured using EQ-5D.
Time frame: Day 30(±3), 90(±7), 180(±14), 360(±30) post-randomization
Stroke recurrence rate
New symptoms persisting for \> 24 hours and new lension on the DWI.
Time frame: Day 30(±3) , 90(±7d), 180(±14d) and 360(±30) post-randomization

Study locations

1 of 2 sites recruiting

Emergency Intensive Care Unit
Beijing, Beijing Municipality, China
- shuhua Yuan, PhD · Contact · shuhua_yuan@126.com · +86 18511703655
Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, China
- Guangxu Liu · Contact · bjcyh_yjxbf@163.com · +86 010-85231129
Not yet recruiting

References and documents

Individual participant data

Plan to share: Yes — 1. Primary/secondary efficacy endpoint data 2. Safety data 3. Baseline characteristic dataset 4. Plan Deviation Record

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07049692
Lead sponsor: Beijing Chao Yang Hospital
Responsible party: Jing Yang (Hyperbaric Oxygen Department, Beijing Chao Yang Hospital) — Principal investigator
First posted: Jul 3, 2025
Start date: Jul 22, 2026
Primary completion: Mar 30, 2028 (estimated)
Completion: Mar 30, 2028 (estimated)
Last update: Jul 24, 2026

Study contacts

Shuyuan Yuan

Contact

shuhua_yuan@126.com

+86 18511703665

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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