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Stroke, AcuteNBOLNCT05039697

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

A study testing oxygen in people with Stroke, Acute and Hypoxia-Ischemia, Brain, run by Capital Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
oxygen
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
282 participants
Where
1 siteChina
Study dates
22 Apr 2021to 4 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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。-

Who cannot join

  • 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;
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  • 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;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Baojun Hou

    Beijing, Beijing Municipality, 100053

Other trials in China

About this study

Official title: 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.

Read the 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).

Being tested
oxygen
Medical subject headings
Stroke, Hypoxia-Ischemia, Brain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oxygenOther

    deliver high flow oxygen (10L/min)

Study groups in NCT05039697
Study groupRoleWhat they receive
NBO group Normobaric Hyperoxia combined with endovascular mechanical thrombectomyExperimentalWithin 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.
Receives: Other: oxygen
Control group Inhale air placebo plus endovascular mechanical thrombectomyPlacebo comparatorFor 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%
Receives: Other: oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Rankin Scale

    the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability,and 6=death)

    Measured: 1 year ± 30 days after randomization

Secondary outcomes (8)

  1. 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.

    Measured: 1 year ± 30 days after randomization

  2. 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

    Measured: 1 year ± 30 days after randomization

  3. Functional independence

    The Proportion of mRS 0-1

    Measured: 1 year ± 30 days after randomization

  4. The Proportion of mRS 0-3

    secondary clinical efficacy endpoint

    Measured: 1 year ± 30 days after randomization

  5. Barthel Index (BI)

    he BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis);

    Measured: 1 year ± 30 days after randomization

  6. All-cause mortality

    clinical safety endpoint;

    Measured: 1 year ± 30 days after randomization

  7. 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.

    Measured: 1 year ± 30 days after randomization

  8. kaplan-meier curve

    clinical efficacy endpoint

    Measured: 1 year ± 30 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2021
  2. Study start22 Apr 2021
  3. Primary completion4 Feb 2024
  4. Study completion4 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05039697
Sponsor's protocol ID
OPENS-2L
Acronym
NBOL
Status last verified
Feb 2025
First submitted
6 Apr 2021
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40520063

Questions about this trial

What is this clinical trial studying?

A study testing oxygen in people with Stroke, Acute and Hypoxia-Ischemia, Brain, run by Capital Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Rankin Scale (time frame: 1 year ± 30 days after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05039697, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.

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