NCT06666764RecruitingPhase 3
Normobaric Oxygen in AIS Transferred for EVT
Adjuvant Normobaric Hyperoxia in Acute Ischemic Stroke Patients Transferred for Thrombectomy
Source: ClinicalTrials.gov · Last updated 11 Dec 2025
Brief summary (registry, in English)
The primary objective of this study is to estimate the efficacy and safety of NBO on 3-month functional outcome after acute ischemic stroke
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1500 (estimated)
- First submitted
- 27 Oct 2024
- Start date
- 13 Dec 2024
- Primary completion date
- Oct 2027
- Lead sponsor
- Capital Medical University
- Diseases
- Stroke
- NCT number
- NCT06666764
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1500
- From 13 Dec 2024 to the primary completion date, Oct 2027
- 112 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Rapidly improving neurological deficits or transient ischemic attack prior to consent;
- Participating in another clinical treatment trial, or completed participation within prior 30 days;
- Receiving other cerebral protective agent (e.g., edaravone dexborneol, n-butylphthalide);
Other illness
- Seizure at stroke onset;
- Signs and symptoms suggestive of subarachnoid hemorrhage, even if CT scan is normal;
- Evidence of acute intracranial hemorrhage on CT/MRI;
Other
- Respiratory rate \<= 10 or \>= 30 breaths per minute;
- Oxygen-dependence at baseline to maintain SaO2 \> 95% or intubation at baseline;
- Exhibiting symptoms of vomiting, or severe headache, or unconscious;
- Evidence of intracranial tumor (except small meningioma) or arteriovenous malformation;
- Woman of childbearing potential known to be pregnant or with a positive pregnancy test;
- Life expectancy \< 90 days due to comorbidity;
- Unlikely to complete the 90-day follow-up;
- Significant mass effect with midline shift, defined as any deviation of midline structures such as the septum pellucidum, is observed on CT/MRI scans.
Who the study is looking for
- Age at least 18 years old;
- 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);
- No prior stroke in the last 3 months;
- Time from stroke onset (last seen well) to randomization is within 9 hours;
- (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;
- NIHSS score 0 or 1 in the section of level of consciousness;
- No significant pre-stroke disability (pre-stroke mRS 0--1);
- ASPECTS at least 6 on non-contrast CT;
- Patient is planned for transfer to a EVT-capable hospital for EVT;
- Signed informed consent from the patient or the legally authorized representative (LAR).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (112)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Meixian Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Baoji | China | Not yet recruiting |
| Baoji High-Tech Hospital Coordinator of this site? Confirm its status | Baoji | China | Recruiting |
| Longxian People's Hospital Coordinator of this site? Confirm its status | Baoji | China | Recruiting |
| Caijiapo Hospital Coordinator of this site? Confirm its status | Baoji | China | Recruiting |
| Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Xianxian Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Cangzhou | China | Recruiting |
| Dongguang County People's Hospital Coordinator of this site? Confirm its status | Cangzhou | China | Recruiting |
| Cangzhou Central Hospital Coordinator of this site? Confirm its status | Cangzhou | China | Recruiting |
| Heqing County People's Hospital Coordinator of this site? Confirm its status | Dali | China | Recruiting |
| Yongping County People's Hospital Coordinator of this site? Confirm its status | Dali | China | Recruiting |
| Yangbi County People's Hospital Coordinator of this site? Confirm its status | Dali | China | Recruiting |
| Binchuan County Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Dali | China | Recruiting |
| Nanjian Yi Autonomous County People's Hospital Coordinator of this site? Confirm its status | Dali | China | Recruiting |
| Midu County People's Hospital Coordinator of this site? Confirm its status | Dali | China | Recruiting |
| Binchuan County People's Hospital Coordinator of this site? Confirm its status | Dali | China | Recruiting |
| Dali Prefecture People's Hospital Coordinator of this site? Confirm its status | Dali | China | Recruiting |
| Jianchuan County People's Hospital Coordinator of this site? Confirm its status | Dali | China | Recruiting |
| Dexing People's Hospital Coordinator of this site? Confirm its status | Dexing | China | Recruiting |
| Hubei Minzu University Affiliated Minzu Hospital Coordinator of this site? Confirm its status | Enshi | China | Recruiting |
| Minqing County General Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Lianjiang County General Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Fujian Medical University First Affiliated Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Fuzhou Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Guangchang County People's Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Fuqing Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Zixi County People's Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Fuqing Second Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Yongtai County Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Jinxi County People's Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Fujian Minhou County Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Fuzhou Changle District People's Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Luoyuan County Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Guangzhou He Xian Memorial Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Jinan University First Affiliated Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Guangzhou Development District Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Yifeng County People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Handan Central Hospital (East Campus) Coordinator of this site? Confirm its status | Handan | China | Recruiting |
| Daming County Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Handan | China | Recruiting |
| Handan Fourth Hospital Coordinator of this site? Confirm its status | Handan | China | Recruiting |
| Quzhou County Hospital Coordinator of this site? Confirm its status | Handan | China | Recruiting |
| Linzhang County People's Hospital Coordinator of this site? Confirm its status | Handan | China | Recruiting |
| Zhaoping County People's Hospital Coordinator of this site? Confirm its status | Hezhou | China | Recruiting |
| Hezhou Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Hezhou | China | Recruiting |
| Fuchuan Yao Autonomous County Ethnic Medicine Hospital Coordinator of this site? Confirm its status | Hezhou | China | Recruiting |
| Huangmei County People's Hospital Coordinator of this site? Confirm its status | Huanggang | China | Recruiting |
| Yongfeng County Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Ji’an | China | Recruiting |
| Xingan County People's Hospital Coordinator of this site? Confirm its status | Ji’an | China | Recruiting |
| Xiajiang County People's Hospital Coordinator of this site? Confirm its status | Ji’an | China | Recruiting |
| Jincheng First People's Hospital Coordinator of this site? Confirm its status | Jinzhong | China | Recruiting |
| Xiyang County People's Hospital Coordinator of this site? Confirm its status | Jinzhong | China | Recruiting |
| Dean County Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Jiujiang | China | Recruiting |
| Jiujiang First People's Hospital Coordinator of this site? Confirm its status | Jiujiang | China | Recruiting |
| Hukou County People's Hospital Coordinator of this site? Confirm its status | Jiujiang | China | Recruiting |
| Dean County People's Hospital Coordinator of this site? Confirm its status | Jiujiang | China | Recruiting |
| Pengze County People's Hospital Coordinator of this site? Confirm its status | Jiujiang | China | Recruiting |
| Songming County People's Hospital Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| Yunnan Provincial First People's Hospital Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| Jinning District People's Hospital Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| Yiliang First People's Hospital Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| Kunming Medical University Yan'an Hospital Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| Chenggong District People's Hospital Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| Liaocheng People's Hospital Coordinator of this site? Confirm its status | Liaocheng | China | Recruiting |
| Lichuan Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Lichuan | China | Recruiting |
| Wenshui County People's Hospital Coordinator of this site? Confirm its status | Lüliang | China | Recruiting |
| Song County People's Hospital Coordinator of this site? Confirm its status | Luoyang | China | Recruiting |
| Xin'an County People's Hospital Coordinator of this site? Confirm its status | Luoyang | China | Recruiting |
| Luoyang Central Hospital Coordinator of this site? Confirm its status | Luoyang | China | Recruiting |
| Yichuan County People's Hospital Coordinator of this site? Confirm its status | Luoyang | China | Recruiting |
| Lushan People's Hospital Coordinator of this site? Confirm its status | Lushancun | China | Recruiting |
| Mudanjiang Second People's Hospital Coordinator of this site? Confirm its status | Mudanjiang | China | Recruiting |
| Linkou County People's Hospital Coordinator of this site? Confirm its status | Mudanjiang | China | Recruiting |
| Jiangxi Provincial People's Hospital Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Anyi County People's Hospital Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Xinjian District People's Hospital Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Gutian County Hospital Coordinator of this site? Confirm its status | Ningde | China | Recruiting |
| Putian Hanjiang District Hospital Coordinator of this site? Confirm its status | Putian | China | Recruiting |
| Fuyuan County People's Hospital Coordinator of this site? Confirm its status | Qujing | China | Recruiting |
| The First People's Hospital Of Qujing Coordinator of this site? Confirm its status | Qujing | China | Recruiting |
| Shizong County People's Hospital Coordinator of this site? Confirm its status | Qujing | China | Recruiting |
| Poyang County People's Hospital Coordinator of this site? Confirm its status | Shangrao | China | Recruiting |
| Wannian County People's Hospital Coordinator of this site? Confirm its status | Shangrao | China | Recruiting |
| Feicheng Hospital of Shandong Yiyang Health Group Coordinator of this site? Confirm its status | Tai’an | China | Recruiting |
| Shanxi Provincial People's Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| Xuanwei First People's Hospital Coordinator of this site? Confirm its status | Xuanwei | China | Recruiting |
| Shanggao County People's Hospital Coordinator of this site? Confirm its status | Yichun | China | Recruiting |
| Fengxin County People's Hospital Coordinator of this site? Confirm its status | Yichun | China | Recruiting |
| Yima People's Hospital Coordinator of this site? Confirm its status | Yima | China | Recruiting |
| Yimei General Hospital Coordinator of this site? Confirm its status | Yima | China | Recruiting |
| Yujiang District People's Hospital Coordinator of this site? Confirm its status | Yingtan | China | Recruiting |
| Yuxi Zhongshan Hospital Coordinator of this site? Confirm its status | Yuxi | China | Recruiting |
| Zhangshu People's Hospital Coordinator of this site? Confirm its status | Zhangshu | China | Recruiting |
| Zhangzhou Hospital Headquarters (High-Tech Campus) Coordinator of this site? Confirm its status | Zhangzhou | China | Recruiting |
| Zhangzhou Fifth Hospital Coordinator of this site? Confirm its status | Zhangzhou | China | Recruiting |
| Zhangpu County Hospital Coordinator of this site? Confirm its status | Zhangzhou | China | Recruiting |
| Nanjing County Hospital Coordinator of this site? Confirm its status | Zhangzhou | China | Recruiting |
| Zhao'an County Hospital Coordinator of this site? Confirm its status | Zhangzhou | China | Recruiting |
| Yunxiao County Hospital Coordinator of this site? Confirm its status | Zhangzhou | China | Recruiting |
| Yunxiao County Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Zhangzhou | China | Recruiting |
| Zhangzhou Second Hospital Coordinator of this site? Confirm its status | Zhangzhou | China | Recruiting |
| Zhangpu County Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Zhangzhou | China | Recruiting |
| Zhangzhou Hospital Coordinator of this site? Confirm its status | Zhangzhou | China | Recruiting |
| Zhangzhou Gulei Port Economic Development Zone First Hospital Coordinator of this site? Confirm its status | Zhangzhou | China | Recruiting |
| Dongshan County Hospital Coordinator of this site? Confirm its status | Zhangzhou | China | Recruiting |
| Pinghe County Hospital Coordinator of this site? Confirm its status | Zhangzhou | China | Recruiting |
| Zhangzhou Changtai District Hospital Coordinator of this site? Confirm its status | Zhangzhou | China | Recruiting |
| Xiage Health Center Coordinator of this site? Confirm its status | Zhangzhou | China | Recruiting |
| Zhoukou Central Hospital Coordinator of this site? Confirm its status | Zhoukou | China | Recruiting |
| Danchuan County Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Zhoukou | China | Recruiting |
| Danchuan Central Hospital Coordinator of this site? Confirm its status | Zhoukou | China | Recruiting |
| Luyi Zhenyuan Hospital Coordinator of this site? Confirm its status | Zhoukou | China | Recruiting |
| Shenqiu County People's Hospital Coordinator of this site? Confirm its status | Zhoukou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.