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Completed

NCT Number: NCT05404373

Treatment Duration on Normobaric Hyperoxia in Acute Ischemic Stroke

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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;
  • 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;
  • 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;

Treatment and study plan

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 oxygen

Other

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

Primary outcomes

  1. Cerebral infarct volume

    Time frame: Within 72 hours after randomization

    The infarct volume is evaluated by MRI or CT scan

Secondary outcomes

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

    Time frame: 24hours, 72hours, day7 after randomization

    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)

  2. The proportion of good prognosis

    Time frame: 90 ± 10 days after randomization

    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;

  3. neurological function improvement rate

    Time frame: Time Frame: 24 ± 6 hours

    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);

  4. modified Rankin Scale score (mRS) score

    Time frame: 30 ± 7 days, 90 ± 10 days after randomization;

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

  5. Vascular recanalization rate

    Time frame: Time Frame: 4 hours ± 15 minutes

    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;

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

    Time frame: 24 ± 6 hours, 72 ± 24 hours

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

  7. Incidence of oxygen-related adverse events

    Time frame: 24 ± 6 hours,

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

  8. Incidence of neurologic deterioration;

    Time frame: 24 ± 6 hours;

    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;

  9. Incidence of Symptomatic Intracerebral Hemorrhage

    Time frame: 24± 12 hours hours after randomization

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

  10. Incidence of any intracranial hemorrhage

    Time frame: 24± 12 hours hours after randomization

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

  11. all-cause death rate

    Time frame: 90 ± 10 days after randomization

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

  12. Incidence of adverse events

    Time frame: 90 ± 10 days after randomization

    clinical safety endpoint;

  13. Incidence of surgery-related complications

    Time frame: 24± 12 hours hours after randomization

    clinical safety endpoint;

  14. stroke related death rate

    Time frame: 90 ± 10 days after randomization;

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

  15. Vital signs:respiration(times/min)

    Time frame: 0 hours, 2 hours, 4 hours after randomization;

    clinical safety endpoint;

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

    Time frame: 0 hours, 2 hours, 4 hours after randomization;

    clinical safety endpoint;

  17. Vital signs:blood pressure(mmHg)

    Time frame: 0 hours, 2 hours, 4 hours after randomization;

    clinical safety endpoint;

  18. Vital signs:oxygen saturation (%)

    Time frame: 0 hours, 2 hours, 4 hours after randomization;

    clinical safety endpoint;

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Collaborators

  • Tianjin Huanhu Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 3, 2022
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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