Normobaric Hyperoxia Combined With Endovascular Therapy in Patients With Stroke Within 6 Hours of Onset：Longterm Outcome — NBOL  

Stroke, Acute Clinical Trial

Official title: Normobaric Hyperoxia Combined With Endovascular Therapy in Patients With Stroke Within 6 Hours of Onset：Longterm Outcome Analysis

Status Recruiting

Clinical Trial Summary

The overall incidence of good outcome for AIS following endovascular treatment is only proximately 50%. Whether NBO was safe and effective to improve acute ischemic stroke prognosis is still unclear. The investigators' hypothesis is thatNBO is a safe and effective strategy to improve longterm outcome in AIS patients undergoing endovascular treatment.

Clinical Trial Description

NBO therapy is to deliver high flow oxygen (10L/min) through an oxygen storage mask. This treatment should be started in the emergency room immediately after the patient is randomized into the group, and oxygen should be continued for 4 hours.

In previous clinical studies of NBO, patients who have not receive revascularization often choose NBO for 8 hours, and studies have concluded that oxygen inhalation for more than 10 hours may bring about the risk of oxygen poisoning. However, a too short treatment time may not bring benefits. Secondly, ideally, we want to ensure that stroke patients receive NBO treatment before achieving reperfusion to protect the ischemic brain tissue, and add 1-2 hours after reperfusion. In the clinical environment after the patient arrives in the emergency department, it takes 2-3 hours to complete the revascularization process. Therefore, we believe that 4 hours of oxygen inhalation is reasonable. And our single-center study also supports that NBO treatment for 4 hours is beneficial.

The specific content is as follows: In the emergency room, patients who are assessed for suspected large blood vessels of acute anterior circulation will be randomized after signing the informed consent. If the subject is randomly divided into NBO+ET group, by putting the patient on Oxygen mask, and then immediately give oxygen (10L/min). NBO treatment is no later than half an hour after randomization. Oxygen comes from the hospital's oxygen center and is transported through wall pipes (oxygen concentration: 100%). The oxygen mask and the wall oxygen are connected by a 1.5 meter long oxygen pipe. When the patient is transferred to the operating room, we provide oxygen through a portable oxygen cylinder (capacity: 4L). In addition, in the operating room and intensive care unit, patients continue to be given wall oxygen therapy until the oxygen inhalation lasts for 4 hours. The arterial blood gas was drawn after 4 hours of oxygen inhalation. The control group directly inhales room air through the patient's nasal cavity without using any equipment. At the same time, patients in the control group were also drawn blood gas analysis at corresponding time points (approximately 4 hours after randomization). ;

Related Conditions & MeSH terms

• Brain Ischemia
• ENDOVASCULAR TREATMENT
• Hyperoxia
• Hypoxia
• Hypoxia-Ischemia, Brain
• Ischemia
• Stroke
• Stroke, Acute

• NCT number: NCT05039697
• Study type: Interventional
• Source: Capital Medical University
• Contact: Xunming Ji, MD
• Phone: 01083199439
• Email: jixm@ccmu.edu.cn
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Completion date: April 1, 2024