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Completed

NCT Number: NCT05128422

Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke

The purpose of this study is to evaluate the safety and efficiency of normobaric hyperoxia combined with endovascular treatment for acute ischemic stroke patients with stroke onset 6-24 hours.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Endovascular Treatment Nervous System Diseases Neuroprotection Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital of Capital Medical University

Beijing, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age≥18;
  • Suspected lage vessel occlusion of acute anterior circulation occlusion; i.e. either the ICA or the M1/M2-segment of the MCA;
  • Stroke symptom onset has been more than 6 hours but not more than 24 hours,and imaging confirmed the existenceof ischemic penumbra;
  • NIHSS score≥6;
  • Alberta Stroke Program Early CT score (ASPECTS) of 6-10 on non- contrast CT;
  • (Level of consciousness) NIHSS score of 0 or 1
  • mRS score was 0-1 before stroke;
  • Informed consent obtained;

Exclusion criteria

  • 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;
  • 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);
  • Patients with upper gastrointestinal bleeding or nausea and vomiting who cannot use oxygen masks;
  • Other circumstances requiring emergency oxygen inhalation;

Treatment and study plan

Normobaric oxygen therapy

Other

it is simple to administer via oxygen storage facemask at flow rates of 10 L/min for 4 hours.This therapy should begin in the emergency room as early as possible when patients meet the inclusion criteria and are randomized to the experimental group

Primary outcomes

  1. Early neurologic improvement (ENI) at 24 hours

    Time frame: 24 ± 12 hours

    ENI was defined as percent change NIHSS≥30%; Percent change NIHSS was defined as [(admission NIHSS score-24-hour NIHSS score)x100/admission NIHSS score];

Secondary outcomes

  1. National Institutes of Health Stroke Scale(NIHSS) Score

    Time frame: 4 hours ± 15 minutes, 24 ± 12 hours; 7 ± 2 days after randomization

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

  2. modified Rankin Scale score (mRS)

    Time frame: 90 ± 14 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)

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

    Time frame: 24 ± 12 hours after randomization

    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)

  4. Barthel Index (BI)

    Time frame: 90 ± 14 days after randomization

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

  5. Revascularization on 24-hour follow-up imaging

    Time frame: 24 ± 12 hours hours after randomization

    secondary imaging efficacy endpoint;Successful recanalization was defined as mTICI 2b or 3

  6. Early neurologic deterioration

    Time frame: 24 ± 12 hours after randomization

    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;

  7. 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

  8. Mortality

    Time frame: 90 ± 14 days after randomization

    clinical safety endpoint;

  9. Stroke recurrence

    Time frame: 90 ± 14 days，180 ± 30 days after randomization

    clinical safety endpoint;

  10. The 5-level EuroQol five dimensions questionnaire（EQ-5D-5L）score

    Time frame: 90 ± 14 days after randomization

    secondary clinical efficacy endpoint, Quality of Life score; The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

  11. Delta NIHSS

    Time frame: 24 ± 12 hours after randomization

    Delta NIHSS was defined (admission NIHSS score-24-hour NIHSS score).

  12. Percent change NIHSS

    Time frame: 24 ± 12 hours after randomization

    Percent change NIHSS was defined as [(admission NIHSS score-24-hour NIHSS score)x100/admission NIHSS score]

  13. Cerebral infarct volume

    Time frame: 36 ± 12 hours after randomization

    Infarct volume is evaluated mainly through brain MRI(DWI) or CT

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients Within 6-24 Hours of Symptom Onset

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 22, 2021
Registry last updated
Jul 31, 2024

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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