NBOLNormobaric Hyperoxia and Endovascular Therapy for Stroke within 6 Hours of Onset
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.
oxygen
Hypoxia+11
+ Brain Diseases
+ Cardiovascular Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.282 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
ExperimentalStudy 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