Oxygen Concentration Target in Stroke Endovascular Treatment
Recruiting now · Not applicable
Conditions studied: Ischemic Stroke
In brief
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.
Key facts
- Study ID
- NCT06224426
- Run by
- Beijing Tiantan Hospital
- People needed
- 200
- Starts
- 2024-02-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2024-12-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years.
- 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.
- NIHSS score at admission: 6-20.
- Randomization can be completed within 24 hours after stroke onset.
You may not qualify if…
- Stroke onset within 6-24 hours with a CT perfusion imaging (CTP)-assessed mismatched area<15 ml.
- Presence of anemia, defined as hemoglobin levels o below 120 g/L in men and below 110 g/L in women.
- Pre-stroke modified Rankin scale (mRS) score ≥2.
- Complicated by severe agitation and seizures.
- Evidence of intracranial hemorrhage at admission.
- Presence of chronic obstructive pulmonary disease, asthma, or other respiratory conditions, or requirement for daily supplemental oxygen or mechanical ventilation.
- 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.
- Emergency chest CT reveals significant pulmonary parenchymal infection.
- An oxygen mask or ventilator must be used before anesthesia to maintain a SpO2≥94%.
- Loss of airway protective reflex or vomiting aspiration upon admission.
Where it is running
- Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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