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

NCT05039697 | Completed DMC

• 1 other identifier: OPENS-2L
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke, Acute; Hypoxia-Ischemia, Brain; ENDOVASCULAR TREATMENT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• EuroQol- 5 Dimension (EQ-5D)

  1 year ± 30 days after randomization

• The proportion of good prognosis

  1 year ± 30 days after randomization

• Functional independence

  1 year ± 30 days after randomization

• The Proportion of mRS 0-3

  1 year ± 30 days after randomization

• Barthel Index (BI)

  1 year ± 30 days after randomization

Study Arms (2)

NBO group Normobaric Hyperoxia combined with endovascular mechanical thrombectomy

EXPERIMENTAL

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

Control group Inhale air placebo plus endovascular mechanical thrombectomy

PLACEBO COMPARATOR

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

Interventions

oxygen OTHER

deliver high flow oxygen (10L/min)

Control group Inhale air placebo plus endovascular mechanical thrombectomy; NBO group Normobaric Hyperoxia combined with endovascular mechanical thrombectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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。-

You may not qualify if:

• 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;

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Baojun Hou

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (1)

• Wei M, Wang X, Wang S, Liu S, Ji X, Li W. Protocol for a prospective 1-year follow-up investigation on normobaric hyperoxia in conjunction with endovascular treatment for acute ischemic stroke (OPENS-2L) trial. Brain Circ. 2025 Mar 31;11(2):127-134. doi: 10.4103/bc.bc_29_24. eCollection 2025 Apr-Jun.

  PMID: 40520063 DERIVED

MeSH Terms

Conditions

Stroke; Hypoxia-Ischemia, Brain

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Hypoxia, Brain; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Xunming Ji, MD

  Xuan Wu Hospital#Capital Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: September 9, 2021
• Study Start: April 22, 2021
• Primary Completion: February 4, 2024
• Study Completion: February 4, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)