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Can breathing pure oxygen boost stroke recovery?

NCT ID NCT06666764

Disease control Sponsor: Capital Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving patients 100% oxygen (normobaric hyperoxia) before a clot-removal procedure can improve their recovery three months after a severe stroke. About 1,500 adults with acute ischemic stroke will be randomly assigned to receive either the extra oxygen or standard care alone. The goal is to see if this simple, low-cost approach reduces long-term disability.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
100% oxygen (normobaric hyperoxia)
What this could lead to
If it works, this could provide a simple, low-cost way to improve functional recovery after a severe stroke.
What could go wrong
This is a large Phase 3 trial, but the intervention is an add-on to standard care, so any benefit may be modest. Oxygen therapy also carries risks like lung irritation or worsened brain injury in some cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age at least 18 years old; 2. Signs and symptoms are consistent with a new acute stroke, with low possibility of stroke mimics (e.g., no sudden coma, prior seizure disorder, suspected hypoglycemia); 3. No prior stroke in the last 3 months; 4. Time from stroke onset (last seen well) to randomization is within 9 hours; 5. (1) Baseline NIHSS score at 6 or more and Intracranial ICA or MCA-M1 or MCA-M2 dominant occlusion, with or without tandem cervical carotid stenosis or tandem cervical occlusion, confirmed by preoperative CTA (or MRA, DSA) and consistent with signs and symptoms; or (2) Baseline NIHSS score at 6 or more with a hyperdense MCA sign on non-contrast CT; or (3) Baseline NIHSS score at 12 or more; 6. NIHSS score 0 or 1 in the section of level of consciousness; 7. No significant pre-stroke disability (pre-stroke mRS 0--1); 8. ASPECTS at least 6 on non-contrast CT; 9. Patient is planned for transfer to a EVT-capable hospital for EVT; 10. Signed informed consent from the patient or the legally authorized representative (LAR). Exclusion Criteria: 1. Known history of severe chronic obstructive pulmonary disease (FEV1 less than 1.0), New York Heart Association (NYHA) Heart Failure Class III or IV, acute pulmonary infection or aspiration pneumonia, prior to enrollment; 2. Respiratory rate \<= 10 or \>= 30 breaths per minute; 3. Oxygen-dependence at baseline to maintain SaO2 \> 95% or intubation at baseline; 4. Seizure at stroke onset; 5. Exhibiting symptoms of vomiting, or severe headache, or unconscious; 6. Rapidly improving neurological deficits or transient ischemic attack prior to consent; 7. Signs and symptoms suggestive of subarachnoid hemorrhage, even if CT scan is normal; 8. Evidence of intracranial tumor (except small meningioma) or arteriovenous malformation; 9. Woman of childbearing potential known to be pregnant or with a positive pregnancy test; 10. Life expectancy \< 90 days due to comorbidity; 11. Unlikely to complete the 90-day follow-up; 12. Participating in another clinical treatment trial, or completed participation within prior 30 days; 13. Receiving other cerebral protective agent (e.g., edaravone dexborneol, n-butylphthalide); 14. Evidence of acute intracranial hemorrhage on CT/MRI; 15. Significant mass effect with midline shift, defined as any deviation of midline structures such as the septum pellucidum, is observed on CT/MRI scans.

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ischemic stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    112 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Anyi County People's Hospital

    RECRUITING

    Nanchang, Jiangxi, China

  • Baoji High-Tech Hospital

    RECRUITING

    Baoji, Shaanxi, China

  • Binchuan County People's Hospital

    RECRUITING

    Dali, Yunnan, China

  • Binchuan County Traditional Chinese Medicine Hospital

    RECRUITING

    Dali, Yunnan, China

  • Caijiapo Hospital

    RECRUITING

    Baoji, Shaanxi, China

  • Cangzhou Central Hospital

    RECRUITING

    Cangzhou, Hebei, China

  • Chenggong District People's Hospital

    RECRUITING

    Kunming, Yunnan, China

  • Dali Prefecture People's Hospital

    RECRUITING

    Dali, Yunnan, China

  • Daming County Traditional Chinese Medicine Hospital

    RECRUITING

    Handan, Hebei, China

  • Danchuan Central Hospital

    RECRUITING

    Zhoukou, Hennan, China

  • Danchuan County Traditional Chinese Medicine Hospital

    RECRUITING

    Zhoukou, Henan, China

  • Dean County People's Hospital

    RECRUITING

    Jiujiang, Jiangxi, China

  • Dean County Traditional Chinese Medicine Hospital

    RECRUITING

    Jiujiang, Jiangxi, China

  • Dexing People's Hospital

    RECRUITING

    Dexing, Jiangxi, China

  • Dongguang County People's Hospital

    RECRUITING

    Cangzhou, Hebei, China

  • Dongshan County Hospital

    RECRUITING

    Zhangzhou, Fujian, China

  • Feicheng Hospital of Shandong Yiyang Health Group

    RECRUITING

    Tai’an, Shandong, China

  • Fengxin County People's Hospital

    RECRUITING

    Yichun, Jiangxi, China

  • Fuchuan Yao Autonomous County Ethnic Medicine Hospital

    RECRUITING

    Hezhou, Guangxi, China

  • Fujian Medical University First Affiliated Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Fujian Minhou County Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Fuqing Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Fuqing Second Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Fuyuan County People's Hospital

    RECRUITING

    Qujing, Yunnan, China

  • Fuzhou Changle District People's Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Fuzhou Traditional Chinese Medicine Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Guangchang County People's Hospital

    RECRUITING

    Fuzhou, Jiangxi, China

  • Guangzhou Development District Hospital

    RECRUITING

    Guangzhou, Guangdong, China

  • Guangzhou He Xian Memorial Hospital

    RECRUITING

    Guangzhou, Guangdong, China

  • Gutian County Hospital

    RECRUITING

    Ningde, Fujian, China

  • Handan Central Hospital (East Campus)

    RECRUITING

    Handan, Hebei, China

  • Handan Fourth Hospital

    RECRUITING

    Handan, Hebei, China

    Contact Email: •••••@•••••

  • Heqing County People's Hospital

    RECRUITING

    Dali, Yunnan, China

  • Hezhou Traditional Chinese Medicine Hospital

    RECRUITING

    Hezhou, Guangxi, China

  • Huangmei County People's Hospital

    RECRUITING

    Huanggang, Hubei, China

  • Hubei Minzu University Affiliated Minzu Hospital

    RECRUITING

    Enshi, Hubei, China

  • Hukou County People's Hospital

    RECRUITING

    Jiujiang, Jiangxi, China

  • Jianchuan County People's Hospital

    RECRUITING

    Dali, Yunnan, China

  • Jiangxi Provincial People's Hospital

    RECRUITING

    Nanchang, Jiangxi, China

  • Jinan University First Affiliated Hospital

    RECRUITING

    Guangzhou, Guangdong, China

  • Jincheng First People's Hospital

    RECRUITING

    Jinzhong, Shanxi, China

  • Jinning District People's Hospital

    RECRUITING

    Kunming, Yunnan, China

  • Jinxi County People's Hospital

    RECRUITING

    Fuzhou, Jiangxi, China

  • Jiujiang First People's Hospital

    RECRUITING

    Jiujiang, Jiangxi, China

  • Kunming Medical University Yan'an Hospital

    RECRUITING

    Kunming, Yunnan, China

  • Lianjiang County General Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Liaocheng People's Hospital

    RECRUITING

    Liaocheng, Shandong, China

  • Lichuan Traditional Chinese Medicine Hospital

    RECRUITING

    Lichuan, Hubei, China

  • Linkou County People's Hospital

    RECRUITING

    Mudanjiang, Heilongjiang, China

  • Linzhang County People's Hospital

    RECRUITING

    Handan, Hebei, China

  • Longxian People's Hospital

    RECRUITING

    Baoji, Shaanxi, China

  • Luoyang Central Hospital

    RECRUITING

    Luoyang, Henan, China

    Contact Email: •••••@•••••

  • Luoyuan County Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Lushan People's Hospital

    RECRUITING

    Lushancun, Jiangxi, China

  • Luyi Zhenyuan Hospital

    RECRUITING

    Zhoukou, Henan, China

  • Meixian Traditional Chinese Medicine Hospital

    NOT_YET_RECRUITING

    Baoji, Shaanxi, China

  • Midu County People's Hospital

    RECRUITING

    Dali, Yunnan, China

  • Minqing County General Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Mudanjiang Second People's Hospital

    RECRUITING

    Mudanjiang, Heilongjiang, China

  • Nanjian Yi Autonomous County People's Hospital

    RECRUITING

    Dali, Yunnan, China

  • Nanjing County Hospital

    RECRUITING

    Zhangzhou, Fujian, China

  • Pengze County People's Hospital

    RECRUITING

    Jiujiang, Jiangxi, China

  • Pinghe County Hospital

    RECRUITING

    Zhangzhou, Fujian, China

  • Poyang County People's Hospital

    RECRUITING

    Shangrao, Jiangxi, China

  • Putian Hanjiang District Hospital

    RECRUITING

    Putian, Fujian, China

  • Quzhou County Hospital

    RECRUITING

    Handan, Hebei, China

  • Shanggao County People's Hospital

    RECRUITING

    Yichun, Jiangxi, China

  • Shanxi Provincial People's Hospital

    RECRUITING

    Taiyuan, Shanxi, China

  • Shenqiu County People's Hospital

    RECRUITING

    Zhoukou, Henan, China

  • Shizong County People's Hospital

    RECRUITING

    Qujing, Yunnan, China

  • Song County People's Hospital

    RECRUITING

    Luoyang, Henan, China

  • Songming County People's Hospital

    RECRUITING

    Kunming, Yunnan, China

  • The First People's Hospital of Qujing

    RECRUITING

    Qujing, Yunnan, 655000, China

  • Wannian County People's Hospital

    RECRUITING

    Shangrao, Jiangxi, China

  • Wenshui County People's Hospital

    RECRUITING

    Lüliang, Shanxi, China

  • Xiage Health Center

    RECRUITING

    Zhangzhou, Fujian, China

  • Xiajiang County People's Hospital

    RECRUITING

    Ji’an, Jiangxi, China

  • Xianxian Traditional Chinese Medicine Hospital

    RECRUITING

    Cangzhou, Hebei, China

  • Xin'an County People's Hospital

    RECRUITING

    Luoyang, Henan, China

  • Xingan County People's Hospital

    RECRUITING

    Ji’an, Jiangxi, China

  • Xinjian District People's Hospital

    RECRUITING

    Nanchang, Jiangxi, China

  • Xiyang County People's Hospital

    RECRUITING

    Jinzhong, Shanxi, China

  • Xuanwei First People's Hospital

    RECRUITING

    Xuanwei, Yunnan, China

  • Xuanwu Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100053, China

  • Yangbi County People's Hospital

    RECRUITING

    Dali, Yunnan, China

  • Yichuan County People's Hospital

    RECRUITING

    Luoyang, Henan, China

  • Yifeng County People's Hospital

    RECRUITING

    Guangzhou, Guangdong, China

  • Yiliang First People's Hospital

    RECRUITING

    Kunming, Yunnan, China

  • Yima People's Hospital

    RECRUITING

    Yima, Henan, China

  • Yimei General Hospital

    RECRUITING

    Yima, Henan, China

  • Yongfeng County Traditional Chinese Medicine Hospital

    RECRUITING

    Ji’an, Jiangxi, China

  • Yongping County People's Hospital

    RECRUITING

    Dali, Yunnan, China

  • Yongtai County Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Yujiang District People's Hospital

    RECRUITING

    Yingtan, Jiangxi, China

  • Yunnan Provincial First People's Hospital

    RECRUITING

    Kunming, Yunnan, China

  • Yunxiao County Hospital

    RECRUITING

    Zhangzhou, Fujian, China

  • Yunxiao County Traditional Chinese Medicine Hospital

    RECRUITING

    Zhangzhou, Fujian, China

  • Yuxi Zhongshan Hospital

    RECRUITING

    Yuxi, Yunnan, China

  • Zhangpu County Hospital

    RECRUITING

    Zhangzhou, Fujian, China

  • Zhangpu County Traditional Chinese Medicine Hospital

    RECRUITING

    Zhangzhou, Fujian, China

  • Zhangshu People's Hospital

    RECRUITING

    Zhangshu, Jiangxi, China

  • Zhangzhou Changtai District Hospital

    RECRUITING

    Zhangzhou, Fujian, China

  • Zhangzhou Fifth Hospital

    RECRUITING

    Zhangzhou, Fujian, China

  • Zhangzhou Gulei Port Economic Development Zone First Hospital

    RECRUITING

    Zhangzhou, Fujian, China

  • Zhangzhou Hospital

    RECRUITING

    Zhangzhou, Fujian, China

  • Zhangzhou Hospital Headquarters (High-Tech Campus)

    RECRUITING

    Zhangzhou, Fujian, China

  • Zhangzhou Second Hospital

    RECRUITING

    Zhangzhou, Fujian, China

  • Zhao'an County Hospital

    RECRUITING

    Zhangzhou, Fujian, China

  • Zhaoping County People's Hospital

    RECRUITING

    Hezhou, Guangxi, China

  • Zhoukou Central Hospital

    RECRUITING

    Zhoukou, Henan, China

  • Zixi County People's Hospital

    RECRUITING

    Fuzhou, Jiangxi, China

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