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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

Full criteria on ClinicalTrials.gov

Sites (112)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Meixian Traditional Chinese Medicine Hospital
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BaojiChinaNot yet recruiting
Baoji High-Tech Hospital
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BaojiChinaRecruiting
Longxian People's Hospital
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BaojiChinaRecruiting
Caijiapo Hospital
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BaojiChinaRecruiting
Xuanwu Hospital, Capital Medical University
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BeijingChinaRecruiting
Xianxian Traditional Chinese Medicine Hospital
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CangzhouChinaRecruiting
Dongguang County People's Hospital
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CangzhouChinaRecruiting
Cangzhou Central Hospital
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CangzhouChinaRecruiting
Heqing County People's Hospital
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DaliChinaRecruiting
Yongping County People's Hospital
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DaliChinaRecruiting
Yangbi County People's Hospital
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DaliChinaRecruiting
Binchuan County Traditional Chinese Medicine Hospital
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DaliChinaRecruiting
Nanjian Yi Autonomous County People's Hospital
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DaliChinaRecruiting
Midu County People's Hospital
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DaliChinaRecruiting
Binchuan County People's Hospital
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DaliChinaRecruiting
Dali Prefecture People's Hospital
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DaliChinaRecruiting
Jianchuan County People's Hospital
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DaliChinaRecruiting
Dexing People's Hospital
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DexingChinaRecruiting
Hubei Minzu University Affiliated Minzu Hospital
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EnshiChinaRecruiting
Minqing County General Hospital
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FuzhouChinaRecruiting
Fujian Medical University Union Hospital
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FuzhouChinaRecruiting
Lianjiang County General Hospital
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FuzhouChinaRecruiting
Fujian Medical University First Affiliated Hospital
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FuzhouChinaRecruiting
Fuzhou Traditional Chinese Medicine Hospital
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FuzhouChinaRecruiting
Guangchang County People's Hospital
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FuzhouChinaRecruiting
Fuqing Hospital
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FuzhouChinaRecruiting
Zixi County People's Hospital
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FuzhouChinaRecruiting
Fuqing Second Hospital
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FuzhouChinaRecruiting
Yongtai County Hospital
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FuzhouChinaRecruiting
Jinxi County People's Hospital
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FuzhouChinaRecruiting
Fujian Minhou County Hospital
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FuzhouChinaRecruiting
Fuzhou Changle District People's Hospital
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FuzhouChinaRecruiting
Luoyuan County Hospital
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FuzhouChinaRecruiting
Guangzhou He Xian Memorial Hospital
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GuangzhouChinaRecruiting
Jinan University First Affiliated Hospital
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GuangzhouChinaRecruiting
Guangzhou Development District Hospital
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GuangzhouChinaRecruiting
Yifeng County People's Hospital
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GuangzhouChinaRecruiting
Handan Central Hospital (East Campus)
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HandanChinaRecruiting
Daming County Traditional Chinese Medicine Hospital
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HandanChinaRecruiting
Handan Fourth Hospital
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HandanChinaRecruiting
Quzhou County Hospital
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HandanChinaRecruiting
Linzhang County People's Hospital
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HandanChinaRecruiting
Zhaoping County People's Hospital
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HezhouChinaRecruiting
Hezhou Traditional Chinese Medicine Hospital
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HezhouChinaRecruiting
Fuchuan Yao Autonomous County Ethnic Medicine Hospital
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HezhouChinaRecruiting
Huangmei County People's Hospital
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HuanggangChinaRecruiting
Yongfeng County Traditional Chinese Medicine Hospital
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Ji’anChinaRecruiting
Xingan County People's Hospital
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Ji’anChinaRecruiting
Xiajiang County People's Hospital
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Ji’anChinaRecruiting
Jincheng First People's Hospital
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JinzhongChinaRecruiting
Xiyang County People's Hospital
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JinzhongChinaRecruiting
Dean County Traditional Chinese Medicine Hospital
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JiujiangChinaRecruiting
Jiujiang First People's Hospital
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JiujiangChinaRecruiting
Hukou County People's Hospital
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JiujiangChinaRecruiting
Dean County People's Hospital
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JiujiangChinaRecruiting
Pengze County People's Hospital
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JiujiangChinaRecruiting
Songming County People's Hospital
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KunmingChinaRecruiting
Yunnan Provincial First People's Hospital
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KunmingChinaRecruiting
Jinning District People's Hospital
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KunmingChinaRecruiting
Yiliang First People's Hospital
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KunmingChinaRecruiting
Kunming Medical University Yan'an Hospital
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KunmingChinaRecruiting
Chenggong District People's Hospital
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KunmingChinaRecruiting
Liaocheng People's Hospital
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LiaochengChinaRecruiting
Lichuan Traditional Chinese Medicine Hospital
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LichuanChinaRecruiting
Wenshui County People's Hospital
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LüliangChinaRecruiting
Song County People's Hospital
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LuoyangChinaRecruiting
Xin'an County People's Hospital
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LuoyangChinaRecruiting
Luoyang Central Hospital
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LuoyangChinaRecruiting
Yichuan County People's Hospital
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LuoyangChinaRecruiting
Lushan People's Hospital
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LushancunChinaRecruiting
Mudanjiang Second People's Hospital
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MudanjiangChinaRecruiting
Linkou County People's Hospital
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MudanjiangChinaRecruiting
Jiangxi Provincial People's Hospital
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NanchangChinaRecruiting
Anyi County People's Hospital
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NanchangChinaRecruiting
Xinjian District People's Hospital
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NanchangChinaRecruiting
Gutian County Hospital
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NingdeChinaRecruiting
Putian Hanjiang District Hospital
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PutianChinaRecruiting
Fuyuan County People's Hospital
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QujingChinaRecruiting
The First People's Hospital Of Qujing
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QujingChinaRecruiting
Shizong County People's Hospital
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QujingChinaRecruiting
Poyang County People's Hospital
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ShangraoChinaRecruiting
Wannian County People's Hospital
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ShangraoChinaRecruiting
Feicheng Hospital of Shandong Yiyang Health Group
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Tai’anChinaRecruiting
Shanxi Provincial People's Hospital
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TaiyuanChinaRecruiting
Xuanwei First People's Hospital
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XuanweiChinaRecruiting
Shanggao County People's Hospital
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YichunChinaRecruiting
Fengxin County People's Hospital
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YichunChinaRecruiting
Yima People's Hospital
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YimaChinaRecruiting
Yimei General Hospital
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YimaChinaRecruiting
Yujiang District People's Hospital
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YingtanChinaRecruiting
Yuxi Zhongshan Hospital
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YuxiChinaRecruiting
Zhangshu People's Hospital
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ZhangshuChinaRecruiting
Zhangzhou Hospital Headquarters (High-Tech Campus)
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ZhangzhouChinaRecruiting
Zhangzhou Fifth Hospital
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ZhangzhouChinaRecruiting
Zhangpu County Hospital
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ZhangzhouChinaRecruiting
Nanjing County Hospital
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ZhangzhouChinaRecruiting
Zhao'an County Hospital
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ZhangzhouChinaRecruiting
Yunxiao County Hospital
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ZhangzhouChinaRecruiting
Yunxiao County Traditional Chinese Medicine Hospital
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ZhangzhouChinaRecruiting
Zhangzhou Second Hospital
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ZhangzhouChinaRecruiting
Zhangpu County Traditional Chinese Medicine Hospital
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ZhangzhouChinaRecruiting
Zhangzhou Hospital
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ZhangzhouChinaRecruiting
Zhangzhou Gulei Port Economic Development Zone First Hospital
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ZhangzhouChinaRecruiting
Dongshan County Hospital
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ZhangzhouChinaRecruiting
Pinghe County Hospital
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ZhangzhouChinaRecruiting
Zhangzhou Changtai District Hospital
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ZhangzhouChinaRecruiting
Xiage Health Center
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ZhangzhouChinaRecruiting
Zhoukou Central Hospital
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ZhoukouChinaRecruiting
Danchuan County Traditional Chinese Medicine Hospital
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ZhoukouChinaRecruiting
Danchuan Central Hospital
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ZhoukouChinaRecruiting
Luyi Zhenyuan Hospital
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ZhoukouChinaRecruiting
Shenqiu County People's Hospital
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ZhoukouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.