Comparing oxygen levels during stroke treatment
Oxygenation Targets for Endovascular Therapy in Acute Ischemic Stroke Patients (Oxy-TARGET)
This study is testing whether giving patients with a stroke high or low levels of oxygen during treatment can help them recover better and safely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06224426 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of different concentrations of normobaric oxygen on early neurological improvement in patients with acute ischemic stroke undergoing endovascular therapy. Participants will be randomly assigned to receive either high-concentration oxygen (FiO2=80%) or low-concentration oxygen (FiO2=30%) during the procedure. The study will assess both the efficacy of oxygen concentration on neurological outcomes and the safety of these oxygen levels. It is a randomized controlled trial planned to enroll 200 patients at Beijing Tiantan Hospital from 2024 to 2026.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with anterior circulation occlusive stroke confirmed by imaging and a NIHSS score between 6 and 20.
Not a fit: Patients with chronic respiratory conditions or those who have had a stroke onset beyond 24 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved neurological outcomes for stroke patients receiving endovascular therapy.
How similar studies have performed: While the specific approach of varying oxygen concentrations during endovascular therapy is novel, similar studies have shown promising results in optimizing oxygen delivery in acute stroke management.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Ruquan Han, Ph.D
- Email: ruquan.han@ccmu.edu.cn
- Phone: +86 13701285393
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.