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Stroke, AcuteNCT03620370

Normobaric Hyperoxia Combined With Reperfusion for Acute Ischemic Stroke

A study testing Normobaric oxygen therapy in people with Stroke, Acute, 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

NBO is a nonpharmacological measure of neuroprotection. The purpose of our study is to evaluate the safety and efficiency of NBO（Normobaric hyperoxia) in the acute ischemic stroke patients who received endovascular treatment. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke, Acute
What is being tested?
Normobaric oxygen therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteChina
Study dates
12 Aug 2018to 19 Oct 2019
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

  • Male or female, age≥18 and ≤ 80;
  • Suspected lage vessel occlusion of acute anterior circulation occlusion; i.e. either the ICA or the M1-segment of the MCA;
  • Acute ischemic stroke where patient is ineligible for intravenous thrombolytic treatment or the treatment is contraindicated, or where patient has received intravenous thrombolytic therapy without recanalization;
  • Patient treatable within 6 hours of symptom onset;or it has been more than 6 hours but not more than 24 hours,and imaging confirmed the existence of ischemic penumbra;
  • NIHSS score≥6分
  • Alberta Stroke Program Early CT score (ASPECTS) of 7-10 on non-contrast CT;
  • Informed consent obtained;

Who cannot join

  • Rapid improvement in neurological status to an NIHSS < 6 or evidence of vessel recanalization prior to randomization;
  • Seizures at stroke onset;
  • Intracranial hemorrhage;
  • Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg, or aggressive treatment intravenous medication)necessary to reduce blood pressure to these limits;
  • Symptoms rapidly improving;
  • Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal;
Show all 19Show fewer
  • Platelet count of less than 100,000 per cubic millimeter;
  • CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere);
  • 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;
  • inability to obtain informed consent;
  • Life expectancy<90 days;
  • Pregnant or breast-feeding women;
  • Unwilling to be followed up or poor compliance for treatment;
  • Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial;
  • Evidence of intracranial tumor;
  • Baseline blood glucose of < 50 mg/dL (2.78 mmol) or > 400 mg/dL (22.20 mmol);

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xuanwu hospital;Capital Medical University

    Beijin

Other trials in China

About this study

Official title: The Safety and Efficacy of Normobaric Hyperoxia Combined With Reperfusion for Acute Ischemic Stroke：A Randomized, Controlled Pilot Study

NBO is a nonpharmacological measure of neuroprotection. The purpose of our study is to evaluate the safety and efficiency of NBO（Normobaric hyperoxia) in the acute ischemic stroke patients who received endovascular treatment. Looking for more clinical evidence for the ischemic stroke patients who will be treated with NBO in the future.

Conditions
Stroke, Acute
Being tested
Normobaric oxygen therapy
Keywords
Normobaric hyperoxia;, Acute ischemic stroke;, vascular recanalization;, Endovascular treatment;, reperfusion therapy
Medical subject headings
Stroke, Ischemic Stroke

What participants receive

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

  • Normobaric oxygen therapyDrug

    In this study, it is simple to administer via oxygen storage facemask at flow rates of 10 L/min for 4 hours. This therapy start should in Pre-hospital or emergency room as early as possible after diagnosed ischemic stroke and uninterrupted during other treatments including mechanical thrombolytic therapy and standard clinical treatment.

Study groups in NCT03620370
Study groupRoleWhat they receive
NBO groupExperimentalNormobaric oxygen therapy is the delivery of high-flow oxygen (10L/min) via oxygen storage facemask. This therapy should start in the pre-hospital or emergency room as soon as possible (within 1 hours) after diagnosis of ischemic stroke and last for 4 hours. All participant will receive mechanical thrombectomy and a standard clinical therapy.
Receives: Drug: Normobaric oxygen therapy
Control groupNo interventionThe participants receive mechanical thrombectomy therapy after diagnosed ischemic. All participants receive a standard clinical therapy.

What is being measured

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

  1. Cerebral infarct volume

    Infarct volume is evaluated mainly through brain MRI(DWI)

    Measured: 24-48h after randomization

Secondary outcomes (16)

  1. levels of blood biomarkers

    Biomarkers for evaluation of BBB damage and brain injury:NSE、S100B、occludin、 claudin-5、MMP-9

    Measured: baseline; 24 ± 6 hours, 7 ± 2 days

  2. modified Rankin Scale score (mRS)

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

    Measured: 30 ± 5 days, 90 ± 10 days after randomization

  3. The good prognosis at 90 days assessed by modified Rankin scale (mRS).

    secondary clinical efficacy endpoint;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: 90 ± 10 days after randomization

  4. Scores assessed by National Institutes of Health Stroke Scale(NIHSS)

    secondary clinical efficacy endpoint; the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits

    Measured: 2 hours ± 15 minutes, 24 ± 6 hours, 7 ± 2 days, 30 ± 5 days after randomization ]

  5. Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours

    secondary clinical efficacy endpoint;the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits)

    Measured: from baseline to 24 ± 6 hours

  6. Improvement of neurologic function after 24h

    NIHSS score decreased by more than 4 points or NIHSS score was 0;secondary clinical efficacy endpoint;the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits)

    Measured: 24 ± 6 hours;

  7. Barthel Index (BI)

    secondary clinical efficacy endpoint;the BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis);

    Measured: 30 ± 5 days, 90 ± 10 days after randomization

  8. Revascularization on 24-hour follow-up imaging

    secondary imaging efficacy endpoint;

    Measured: 24 (12 to 36) hours;

  9. 24-hour neurologic deterioration;

    NIHSS score increased by more than 4 points);the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits);clinical safety endpoint;

    Measured: 24 ± 6 hours;

  10. any intracranial hemorrhage on 24-hour follow-up imaging

    imaging safety endpoints;per ECASS III definition and per Heidelberg bleeding classification

    Measured: 24 (12 to 36) hours

  11. Symptomatic Intracerebral Hemorrhage

    imaging safety endpoints;Deterioration in NIHSS score of ≥4 points within 24 hours;per ECASS III definition and per Heidelberg bleeding classification

    Measured: 24 (12 to 36) hours

  12. Mortality and Stroke recurrence

    clinical safety endpoint;

    Measured: 90 ± 10 days after randomization

  13. Survival rates

    secondary clinical efficacy endpoint;

    Measured: 7 ± 2 days, 90 ± 10 days after randomization

  14. TICI (Thrombolysis in Cerebral Infarction perfusion scale grade)

    secondary imaging efficacy endpoint;

    Measured: Time Frame: 4 hours ± 15 minutes

  15. The infarct volume on 24-hour follow-up imaging

    The infarct volume of cerebral infarct is evaluated by cranial CT;

    Measured: 24 (12 to 36) hours;

  16. mRS4-6

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

    Measured: 90 ± 10 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 posted8 Aug 2018
  2. Study start12 Aug 2018
  3. Primary completion21 Jul 2019
  4. Study completion19 Oct 2019

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
Single blind
Who is masked
Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03620370
Sponsor's protocol ID
OPENS-1
Status last verified
Jul 2020
First submitted
3 Aug 2018
Last updated
19 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Niu H, Ding J, Chen Z, Yuan S, Qi Z, Ji X, Li W. Normobaric Hyperoxia in Patients With Acute Stroke: Enhancing Neuroprotection Through Inhibition of Inflammation. J Am Heart Assoc. 2026 Mar 17;15(6):e041825. doi: 10.1161/JAHA.125.041825. Epub 2025 Oct 9.

    PubMed 41065265

  • Li W, Qi Z, Ma Q, Ding J, Wu C, Song H, Yang Q, Duan J, Liu L, Kang H, Wu L, Ji K, Zhao W, Li C, Sun C, Li N, Fisher M, Ji X, Liu KJ. Normobaric Hyperoxia Combined With Endovascular Treatment for Patients With Acute Ischemic Stroke: A Randomized Controlled Clinical Trial. Neurology. 2022 Aug 23;99(8):e824-e834. doi: 10.1212/WNL.0000000000200775. Epub 2022 Jun 17.

    PubMed 35715198

Questions about this trial

What is this clinical trial studying?

A study testing Normobaric oxygen therapy in people with Stroke, Acute, 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 7 inclusion and 19 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 Jul 2023. 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. 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?

Cerebral infarct volume (time frame: 24-48h 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 NCT03620370, which also lists 2 linked publications.

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 Jul 2023.

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