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COMPLETED
NCT05965687
PHASE3

Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke (OPENS-3)

Sponsor: Ji Xunming,MD,PhD

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the efficacy and safety of Normobaric Hyperoxia combined with intravenous thrombolysis for acute ischemic stroke.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1230

Start Date

2023-08-17

Completion Date

2026-02-16

Last Updated

2026-07-30

Healthy Volunteers

No

Interventions

PROCEDURE

Normobaric Hyperoxia

Within 4.5 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.

PROCEDURE

Nasal oxygen

For nasal oxygen group, patients were immediately given oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 1L/min using nasal cannula 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%.

DRUG

Intravenous thrombolysis(rt-PA)

10% dose of rt-PA (0.9 mg/kg) is given as bolus and the rest given as an infusion over the remaining 1 hour. Maximum dose 90mg.

Locations (1)

Xuan Wu Hospital,Capital Medical University

Beijing, China