Oxygen Concentration Target in Stroke Endovascular Treatment

Launched by BEIJING TIANTAN HOSPITAL · Jan 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how different amounts of oxygen can affect recovery for patients who have had an ischemic stroke, which is caused by a blocked blood vessel in the brain. Specifically, the trial compares the effects of high-concentration oxygen (80%) versus low-concentration oxygen (30%) on early brain function improvements in patients receiving a specific treatment called endovascular therapy (EVT). Researchers want to see if one type of oxygen is better for recovery and if both types are safe for patients during treatment.

To participate in this trial, individuals must be at least 18 years old and have a certain type of stroke confirmed by imaging tests. Eligible participants will receive EVT while under general anesthesia and will be randomly assigned to one of the two oxygen treatments. Participants can expect to be closely monitored during the procedure to ensure their safety. It’s important to note that some people, such as those with severe breathing problems or previous significant disabilities, may not qualify for the study. This trial is currently looking for volunteers, and the goal is to help improve care for future stroke patients.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • 1. Age ≥18 years.
• • 2. Anterior circulation occlusive stroke is confirmed by CT angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography (DSA), and occlusions of intracranial internal carotid artery (ICA) or M1 segment of the middle cerebral artery (MCA) were involved.
• • 3. NIHSS score at admission: 6-20.
• • 4. Randomization can be completed within 24 hours after stroke onset.
• • Exclusion criteria
• • 1. Stroke onset within 6-24 hours with a CT perfusion imaging (CTP)-assessed mismatched area\<15 ml.
• • 2. Presence of anemia, defined as hemoglobin levels o below 120 g/L in men and below 110 g/L in women.
• • 3. Pre-stroke modified Rankin scale (mRS) score ≥2.
• • 4. Complicated by severe agitation and seizures.
• • 5. Evidence of intracranial hemorrhage at admission.
• • 6. Presence of chronic obstructive pulmonary disease, asthma, or other respiratory conditions, or requirement for daily supplemental oxygen or mechanical ventilation.
• • 7. Baseline arterial blood gas analysis indicating impaired gas exchange: PaO2 \< 60 mmHg on room air, or oxygenation index (PaO2/FiO2) \< 300 mmHg with supplemental oxygen.
• • 8. Emergency chest CT reveals significant pulmonary parenchymal infection.
• • 9. An oxygen mask or ventilator must be used before anesthesia to maintain a SpO2≥94%.
• • 10. Loss of airway protective reflex or vomiting aspiration upon admission.

Trial Officials