Normobaric Hyperoxia Combined with Endovascular Therapy in Patients with Stroke Within 6 Hours of Onset：longterm Outcome (NBOL)

Normobaric Hyperoxia Combined with Endovascular Therapy in Patients with Stroke Within 6 Hours of Onset：longterm Outcome Analysis

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Acute; Hypoxia-Ischemia, Brain; ENDOVASCULAR TREATMENT
• Intervention / Treatment: Other: oxygen

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 282
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Baojun Hou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years old.
• The clinical symptoms and signs are consistent with acute anterior circulation large vessel occlusion;
• NIHSS score ≥ 10 points;
• (Level of consciousness) NIHSS score 0 or 1;
• The time from onset to randomization is within 6 hours of onset;
• The mRS score before stroke is 0-1;
• The patient has good compliance and can complete the operation with local anesthesia;
• The patient can cooperate with this study and follow-up in the future
• Patient and family members sign informed consent。-

Exclusion Criteria:

• Rapid neurological function improvement, NIHSS score less than 10 points, or evidence of vessel recanalization prior to randomization;
• Seizures at stroke onset;
• Intracranial hemorrhage;
• Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal;
• Platelet count of less than 100,000 per cubic millimeter;
• Severe hepatic or renal dysfunction;
• Active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;
• >3 L/min oxygen required to maintain peripheral arterial oxygen saturation (SaO2) 95% as per current stroke management guidelines;
• Medically unstable;
• Life expectancy<90 days;
• Evidence of intracranial tumor;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NBO group Normobaric Hyperoxia combined with endovascular mechanical thrombectomy; Within 6 hours after stroke onset, patients were randomized into the NBO group and immediately given 100% oxygen inhalation (no more than 30minutes after admission) at a ventilation rate of 10L/min using a sealed non-ventilating oxygen storagemask 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.	Other: oxygen; deliver high flow oxygen (10L/min)
Placebo Comparator: Control group Inhale air placebo plus endovascular mechanical thrombectomy; For Sham NBO group, Patients were immediately given oxygen inhalation (no more than 30 minutes after admission) 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%	Other: oxygen; deliver high flow oxygen (10L/min)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale	the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability,and 6=death)	1 year ± 30 days after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EuroQol- 5 Dimension (EQ-5D)	EuroQol five dimensions questionnaire (EQ-5D)EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	1 year ± 30 days after randomization
The proportion of good prognosis	the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death);The ratio of 0 to 2	1 year ± 30 days after randomization
Functional independence	The Proportion of mRS 0-1	1 year ± 30 days after randomization
The Proportion of mRS 0-3	secondary clinical efficacy endpoint	1 year ± 30 days after randomization
Barthel Index (BI)	he BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis);	1 year ± 30 days after randomization
All-cause mortality	clinical safety endpoint;	1 year ± 30 days after randomization
New major vascular events	clinical safety endpoint; Major vascular events include fatal or nonfatal cardiac events, fatal or nonfatal stroke, or fatal or nonfatal major peripheral arterial or thrombo-embolic events.	1 year ± 30 days after randomization
kaplan-meier curve	clinical efficacy endpoint	1 year ± 30 days after randomization

Collaborators and Investigators

• Sponsor: Capital Medical University
• Investigators: Study Chair: Xunming Ji, MD, Xuan Wu Hospital#Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Actual): February 4, 2024
• Study Completion (Actual): February 4, 2024

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: September 6, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 16, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Hypoxia, Brain; Stroke; Hypoxia; Brain Ischemia; Hypoxia-Ischemia, Brain; Hyperoxia
• Other Study ID Numbers: OPENS-2L

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No