NCT04681651

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

A Randomized Controlled Trial Assessing the Efficacy and Safety of Normobaric Hyperoxia for Acute Ischemic Stroke Patients Undergoing Endovascular Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 282 (actual)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-04-22
• Primary completion: 2023-05-05
• Completion: 2023-05-05
• First posted: 2020-12-23
• Last updated: 2023-07-06

Locations

1 site across 1 country: China