AzTrials
AzTrials

Stroke, AcuteNCT05404373

Treatment Duration on Normobaric Hyperoxia in Acute Ischemic Stroke

A study testing Normobaric Hyperoxia (NBO) and Low flow oxygen in people with Stroke, Acute and Neuroprotection, 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
Search all trials

Trial summary

Normoxia Hyperoxia (NBO) is a neuroprotective approach that can be implemented early. NBO is simple and non-invasive and can be used at home or in an ambulance to ensure the shortest possible time after cerebral ischemia occurs. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Normobaric Hyperoxia (NBO) and Low flow oxygen
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteChina
Study dates
20 Jun 2022to 30 Sep 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptoms and signs were consistent with acute anterior circulation stroke,
  • NIHSS score≥6分;Alberta Stroke Program Early CT score (ASPECTS)≥6;
  • Met the indications for endovascular therapy;
  • (Level of consciousness)NIHSS score 0 or 1; MRS score was 0-1 before stroke
  • The time from onset to randomization was within 24 hours;
  • Preoperative CTA or MRA confirmed the presence of large vessel occlusion (internal carotid artery or middle cerebral artery M1, M2 segments);
  • Patients and their families signed 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;
  • Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with INR > 3.0 or PTT > 3 times normal;
  • Platelet count of less than 100,000 per cubic millimeter;
Show all 17Show fewer
  • Severe hepatic or renal dysfunction;
  • Severe, sustained hypertension (Systolic Blood Pressure >185 mmHg or Diastolic Blood Pressure >110 mmHg)
  • Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol) 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;
  • Patients who could not complete the 90-day follow-up;
  • Evidence of intracranial tumor;
  • Patients with anemia or polycythemia vera or other situations that require urgent oxygen inhalation;
  • Patients with upper gastrointestinal bleeding or nausea or vomiting so that they cannot cooperate with the mask to inhale oxygen.
  • A history of severe allergies to contrast agents;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin Municipality

Other trials in China

About this study

Official title: The Efficacy and Safety of Normobaric Hyperoxia on Treatment Duration for Acute Ischemic Stroke Patients With Endovascular Treatment

Normoxia Hyperoxia (NBO) is a neuroprotective approach that can be implemented early. NBO is simple and non-invasive and can be used at home or in an ambulance to ensure the shortest possible time after cerebral ischemia occurs. The previous study by the investigators suggested that NBO therapy in the early stage of cerebral ischemia has a neuroprotective effect on ischemic brain injury. Although the neuroprotective effect of NBO has been demonstrated, the optimal duration of treatment for NBO to exert neuroprotective effect is still unclear. Therefore, further discussion of the duration of NBO treatment will contribute to the clinical application of NBO and provide a definite theoretical basis for the treatment of cerebral infarction.

Being tested
Normobaric Hyperoxia (NBO), Low flow oxygen
Medical subject headings
Stroke

What participants receive

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

  • Normobaric Hyperoxia (NBO)Other

    NBO was inhaled as early as possible before revascularization, and inhaled for 1h/2h/4h according to different groups

  • Low flow oxygenOther

    immediately given oxygen inhalation at a ventilation rate of 1L/ min using a oxygen storage mask and keep giving oxygen for 4 hours.

Study groups in NCT05404373
Study groupRoleWhat they receive
Low flow oxygen groupPlacebo comparatorpatients were randomized into the Low flow oxygen group and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 1L/ min using a oxygen storage mask and keep giving oxygen for 4 hours.
Receives: Other: Low flow oxygen
NBO group (2h)Experimentalpatients were randomized into the NBO group (2h) and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 10L/ min using a oxygen storage mask and keep giving oxygen for 2 hours.
Receives: Other: Normobaric Hyperoxia (NBO)
NBO group (4h)Experimentalpatients were randomized into the NBO group (4h) and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 10L/ min using a oxygen storage mask and keep giving oxygen for 4 hours.
Receives: Other: Normobaric Hyperoxia (NBO)
NBO group (6h)Experimentalpatients were randomized into the NBO group (6h) and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 10L/ min using a oxygen storage mask and keep giving oxygen for 6 hours.
Receives: Other: Normobaric Hyperoxia (NBO)

What is being measured

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

  1. Cerebral infarct volume

    The infarct volume is evaluated by MRI or CT scan

    Measured: Within 72 hours after randomization

Secondary outcomes (18)

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

    secondary clinical efficacy endpoint; the NIHSS is a stroke severity score composed of 11 items (range from 0 to 41, higher values indicate more severe deficits)

    Measured: 24hours, 72hours, day7 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;with higher scores indicating more severe disability);The ratio of 0 to 2;

    Measured: 90 ± 10 days after randomization

  3. neurological function improvement rate

    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);

    Measured: Time Frame: 24 ± 6 hours

  4. modified Rankin Scale score (mRS) score

    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 ± 7 days, 90 ± 10 days after randomization;

  5. Vascular recanalization rate

    secondary imaging efficacy endpoint; Extended Treatment In Cerebral Ischemia (eTICI)；The eTICI is an ordinal hierarchical scale ranging from 0 to 3, with higher scores indicating better antegrade reperfusion of the previously occluded target artery ischemic territory; eTICI 2B or 3 are defined as successful recanalization;

    Measured: Time Frame: 4 hours ± 15 minutes

  6. blood biomarkers : occludin(ng/ml), MMP-9(ng/ml), S100B(ng/ml),NSE(ng/ml),GFAP(ng/ml),PGP9.5(ng/ml),etc

    Biomarkers for evaluation of BBB damage , brain injury and inflammation,etc:

    Measured: 24 ± 6 hours, 72 ± 24 hours

  7. Incidence of oxygen-related adverse events

    Including Headache, dizziness, nausea, vomiting, chest tightness, shortness of breath, cough,etc;

    Measured: 24 ± 6 hours,

  8. Incidence of 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;

  9. Incidence of 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 hours hours after randomization

  10. Incidence of any intracranial hemorrhage

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

    Measured: 24± 12 hours hours after randomization

  11. all-cause death rate

    clinical safety endpoint; Ratio of total deaths from all causes to all enrollments

    Measured: 90 ± 10 days after randomization

  12. Incidence of adverse events

    clinical safety endpoint;

    Measured: 90 ± 10 days after randomization

  13. Incidence of surgery-related complications

    clinical safety endpoint;

    Measured: 24± 12 hours hours after randomization

  14. stroke related death rate

    clinical safety endpoint; Stroke-related deaths as a proportion of all participants

    Measured: 90 ± 10 days after randomization;

  15. Vital signs:respiration(times/min)

    clinical safety endpoint;

    Measured: 0 hours, 2 hours, 4 hours after randomization;

  16. Vital signs:heart rate: (times/min)

    clinical safety endpoint;

    Measured: 0 hours, 2 hours, 4 hours after randomization;

  17. Vital signs:blood pressure(mmHg)

    clinical safety endpoint;

    Measured: 0 hours, 2 hours, 4 hours after randomization;

  18. Vital signs:oxygen saturation (%)

    clinical safety endpoint;

    Measured: 0 hours, 2 hours, 4 hours 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 posted3 Jun 2022
  2. Study start20 Jun 2022
  3. Primary completion30 Sep 2023
  4. Study completion30 Sep 2023

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
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05404373
Sponsor's protocol ID
TD-NBO
Status last verified
Jun 2023
First submitted
24 May 2022
Last updated
6 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li W, Wang S, Liu L, Chen J, Lan J, Ding J, Chen Z, Yuan S, Qi Z, Wei M, Ji X. Normobaric Hyperoxia Combined With Endovascular Treatment Based on Temporal Gradient: A Dose-Escalation Study. Stroke. 2024 Jun;55(6):1468-1476. doi: 10.1161/STROKEAHA.123.046106. Epub 2024 May 15.

    PubMed 38747162

Questions about this trial

What is this clinical trial studying?

A study testing Normobaric Hyperoxia (NBO) and Low flow oxygen in people with Stroke, Acute and Neuroprotection, 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 17 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 6 Dec 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. 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?

Cerebral infarct volume (time frame: Within 72 hours 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 NCT05404373, 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 6 Dec 2023; AzTrials last refreshed its copy on 3 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in