NCT06224426 Oxygen Concentration Target in Stroke Endovascular Treatment
| NCT ID | NCT06224426 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-02-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to compare the effects of different concentrations of normobaric oxygen on early neurological improvement in acute ischemic stroke (AIS) patients receiving endovascular therapy (EVT). The main questions it aims to answer are: * Evaluating the impact of normobaric high-concentration oxygen versus low-concentration oxygen on early neurological function after EVT. * Evaluating the safety of high and low normobaric oxygen concentration in patients with ischemic stroke. Participants will (1) receive EVT under general anesthesia; (2) be randomly assigned 1:1 to receive oxygen therapy with FiO2=80% or FiO2=30% through endotracheal intubation during the operation, and the gas flow rate was set at 4L /min.
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.
Contact & Investigator
Ruquan Han, Ph.D
STUDY DIRECTOR
Department of Anesthesiology, Beijing TianTan Hospital, Capital Medical University
Frequently Asked Questions
Who can join the NCT06224426 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06224426 currently recruiting?
Yes, NCT06224426 is actively recruiting participants. Contact the research team at ruquan.han@ccmu.edu.cn for enrollment information.
Where is the NCT06224426 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06224426 clinical trial?
NCT06224426 is sponsored by Beijing Tiantan Hospital. The principal investigator is Ruquan Han, Ph.D at Department of Anesthesiology, Beijing TianTan Hospital, Capital Medical University. The trial plans to enroll 200 participants.
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