Completed

NBOLNormobaric Hyperoxia and Endovascular Therapy for Stroke within 6 Hours of Onset

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Study Aim

This study aims to evaluate the effectiveness of Normobaric Hyperoxia combined with Endovascular Therapy in improving the Modified Rankin Scale, a measure of disability, within 6 hours of stroke onset in stroke patients.

What is being tested

oxygen

Other
Who is being recruted

Hypoxia+11

+ Brain Diseases

+ Cardiovascular Diseases

From 18 to 80 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: April 2021
See protocol details

Summary

Principal SponsorCapital Medical University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 22, 2021

Actual date on which the first participant was enrolled.

This study is about using a treatment called Normobaric Hyperoxia (NBO) combined with Endovascular Therapy (ET) for patients who have experienced a stroke within 6 hours of its onset. The goal is to understand the long-term outcomes of this combined treatment. Stroke patients who are suspected to have blockages in large blood vessels in the front part of the brain are the focus of this study. The importance of this study lies in finding a potential way to protect the brain tissue from damage due to lack of blood supply, which could improve stroke care and outcomes. In this study, patients who are assigned to the NBO+ET group receive high flow oxygen (10L/min) through an oxygen mask, starting in the emergency room immediately after they are randomized into the group. The oxygen is given for 4 hours. This duration is chosen to balance the potential benefits and risks of oxygen inhalation, as longer periods may increase the risk of oxygen poisoning, while shorter periods may not provide enough benefits. The oxygen treatment is ideally started before and continued for a short period after the blood flow is restored. The effectiveness of the treatment is measured using the Modified Rankin Scale, a disability score ranging from 0 (no symptoms) to 6 (death). Patients in the control group breathe room air normally without any additional equipment.

Official TitleNormobaric Hyperoxia Combined With Endovascular Therapy in Patients With Stroke Within 6 Hours of Onset:Longterm Outcome Analysis
NCT05039697
Principal SponsorCapital Medical University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

282 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HypoxiaBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesHypoxia, BrainBrain IschemiaCerebrovascular DisordersNervous System DiseasesSigns and SymptomsSigns and Symptoms, RespiratoryPathological Conditions, Signs and SymptomsVascular DiseasesStrokeHypoxia-Ischemia, Brain

Criteria

9 inclusion criteria required to participate
Level of consciousness) NIHSS score 0 or 1

The patient can cooperate with this study and follow-up in the future

Patient and family members sign informed consent。-

Age >= 18 years old

Show More Criteria

11 exclusion criteria prevent from participating
Life expectancy < 90 days

Active and chronic obstructive pulmonary disease or acute respiratory distress syndrome

Evidence of intracranial tumor

Medically unstable

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Patients in this group receive air placebo through a mask and undergo endovascular mechanical thrombectomy. Oxygen is given if needed, starting at a low rate and increased gradually if oxygen levels drop.

Group II

Experimental
This group receives immediate high flow oxygen treatment for 4 hours after stroke onset, combined with endovascular mechanical thrombectomy. Oxygen is given through a mask at a rate of 10L/min.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Baojun Hou

Beijing, ChinaOpen Baojun Hou in Google Maps
CompletedOne Study Center