Efficiency and Safety Evaluation of Normobaric Hyperoxia Stabilizing the Penumbra in Patients With Acute Ischemic Stroke

Ji Xunming,MD,PhD1 site in 1 country78 target enrollmentMarch 22, 2023

ConditionsAcute Ischemic Stroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Ischemic Stroke
Sponsor: Ji Xunming,MD,PhD
Enrollment: 78
Locations: 1
Primary Endpoint: changing of penumbra volume from baseline
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To investigate the safety and efficacy of normobaric hyperoxia (NBO) stabilizing penumbra in acute ischemic stroke patients.

Detailed Description

All the enrolled patients were randomly assigned to NBO and control group. NBO group will be given 100% oxygen ( (10L/min for 4h) via a storage oxygen face mask and control group will be given oxygen using nasal oxygen(2L/min for 4h) .

Registry

clinicaltrials.gov

Start Date

March 22, 2023

End Date

December 31, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ji Xunming,MD,PhD

Responsible Party

Sponsor Investigator

Principal Investigator

Ji Xunming,MD,PhD

Professor

Capital Medical University

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Evidence of rapid improvement in neurological function and NIHSS score \<6, or spontaneous recanalization before randomization
•The disease affecting assessment of baseline NIHSS score (dementia, epilepsy, neuromuscular disease, or psychiatric disease)
•Symptoms suggesting subarachnoid hemorrhage (even if CT scan is normal)
•Combined with the history, cerebral embolism due to sepsis or infective endocarditis was suspected
•Active or chronic obstructive pulmonary disease, pulmonary fibrosis, pneumonia, pleural effusion, acute respiratory distress syndrome, irregular breathing
•It is necessary to inhale (\>3L/min) oxygen to maintain peripheral arterial oxygen saturation (SaO2\>95%)
•Anemia or polycythemia vera or other conditions needing emergency oxygen patients
•Patients with upper gastrointestinal bleeding or nausea and vomiting can not complete inhalation oxygen using face mask
•Baseline blood glucose \<2.78mmol/L or \>22.2mmol/L
•Baseline platelet count \<50×109/L

Outcomes

Primary Outcomes

changing of penumbra volume from baseline

Time Frame: Day 0

the comparison of ratio of 4h following randomizing and baseline for penumbra volume between NBO and control group

Secondary Outcomes

modified rankin scale (mRS) score at 90 days following randomizing(Month 3)
Barthel Index at 90 days following randomizing(Month 3)
EQ-5D index at 90 days following randomizing(Month 3)
National Institutes of Health Stroke Scale (NIHSS) score at 24h following randomizing(Day 1)
BBB injured biomarkers at baseline and 24h following randomizing(Day 1)
volume of core infarction at 4h following randomizing(Day 0)
penumbra volume at 4h following randomizing(Day 0)
volume of hypoperfusion region hypoperfusion at 4h following randomizing(Day 0)
Cerebral oxygen concentration at baseline and 4h following randomizing(Day 0)