Normobaric Hyperoxia Combined With Endovascular Treatment in Acute Ischemic Stroke (OPENS-2)

Summary

The current endovascular treatment has increased the recanalization rate to more than 90%. Even so, the prognosis rate of stroke is still less than 50%. Our previous research confirmed that the neuroprotective effect of Normobaric Hyperoxia (NBO) from multiple perspectives. However, the clinical study on NBO was not satisfactory, which might be due to the absence of vascular recanalization therapy. Therefore, The investigators conducted this RCT study to further explore the Efficacy and safety of NBO combined with endovascular treatment in patients with acute ischemic stroke.

Conditions

• Stroke, Acute
• Neuroprotection

Interventions

DRUG

Normobaric Hyperoxia

Within 6 hours after stroke onset, patients were randomized into the NBO group and immediately given 100% oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 10L/ min using a sealed non-ventilating oxygen storage mask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain ventilation, the FiO2 should be set to 1.0.

DRUG

Sham Normobaric Hyperoxia

For Sham NBO group, Patients were immediately given oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 1l/min using the same mask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain, the FiO2 should be set to 0.3 and gradualy incerased if spO2≤94%；

PROCEDURE

Endovascular Thrombectomy

EVT is the international guidelines for the treatment of acute ischemic stroke with lage vessel occlusion.

Sponsors & Collaborators

• Tianjin Huanhu Hospital

  collaborator OTHER

• Shengli Oilfield Hospital

  collaborator OTHER

• Beijing Fengtai You'anmen Hospital

  collaborator UNKNOWN

• Jiujiang University Affiliated Hospital

  collaborator OTHER_GOV

• Zhangzhou Municipal Hospital of Fujian Province

  collaborator OTHER

• Baotou Central Hospital

  collaborator OTHER

• Luoyang Central Hospital

  collaborator OTHER

• Nanyang Central Hospital

  collaborator OTHER

• Qingdao Central Hospital

  collaborator OTHER

• The Third People's Hospital of Jinan

  collaborator UNKNOWN

• Rizhao People's Hospital

  collaborator OTHER

• Anyang People's Hospital

  collaborator UNKNOWN

• Shanghai 10th People's Hospital

  collaborator OTHER

• Dalian Municipal Central Hospital

  collaborator OTHER

• Zhoukou Central Hospital

  collaborator OTHER

• Nanshi Hospital of Nanyang

  collaborator UNKNOWN

• The second Nanning People's Hospital

  collaborator UNKNOWN

• Zhumadian Central Hospital

  collaborator OTHER

• Taizhou Hospital

  collaborator OTHER

• Second Affiliated Hospital of Nanchang University

  collaborator OTHER

• Capital Medical University

  lead OTHER

Principal Investigators

• Xunming Ji, MD,PhD · Capital Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-22

Primary Completion

2023-05-05

Completion

2023-05-05

Countries

• China

Study Locations