Oxygen Concentration Target in Stroke Endovascular Treatment

Официальное название

Oxygenation Targets for Endovascular Therapy in Acute Ischemic Stroke Patients (Oxy-TARGET)

Обзор

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.

Подробное описание

The optimal fraction of inspired oxygen (FiO2) during EVT under general anesthesia is currently uncertain. This is a randomized controlled trial (RCT) designed to assess the impact of normobaric high-concentration oxygen versus low-concentration oxygen on early neurological function following EVT. It is a prospective, open-label, parallel-design RCT planned to be conducted at Beijing Tiantan Hospital, Capital Medical University. It is anticipated that 200 cases of AIS patients undergoing EVT under general anesthesia will be consecutively enrolled from 2024 to 2026. Eligible participants will be randomly assigned in a 1:1 ratio. After general anesthesia induction, patients will receive continuous inhalation of oxygen with either FiO2=80% or FiO2=30% through endotracheal intubation until the end of the procedure, with a gas flow rate set at 4 L/min. The positive end-expiratory pressure (PEEP) is uniformly set to 5 cmH2O to balance its effect on pulmonary oxygen delivery. The primary outcome will be the occurrence of early neurological improvement (NIHSS score of 10 points 24±2 hours after EVT). Safety outcomes include potential adverse events such as site infection, three-month mortality, etc.

Вмешательства

• Другое Normobaric high-concentration oxygen
  During endovascular therapy, eligible participants will receive FiO2=80% through endotracheal intubation, with a gas flow rate set at 4 L/min.
• Другое Normobaric low-concentration oxygen
  During endovascular therapy, eligible participants will receive FiO2=30% through endotracheal intubation, with a gas flow rate set at 4 L/min.

Первичные конечные точки

• the incidence of early neurological improvement (ENI) [Срок оценки: 24±2 hours after EVT]

Вторичные конечные точки (6)

• ΔNIHSS at 24±2 hours after EVT [Срок оценки: 24±2 hours after EVT]
• the final infarct volume [Срок оценки: 72 hours post-randomization]
• early neurological deterioration (END) [Срок оценки: 1 day after reperfusion therapy]
• Postoperative pulmonary complications [Срок оценки: within 7 days after endovascular therapy]
• overall mRS distribution at 90 days [Срок оценки: 90 days after stroke onset]
• favorable functional outcome [Срок оценки: 90 days after stroke onset]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital, Capital Medical University — Пекин

Публикации

• Hu Z, Zhang K, Wu Y, Wang X, Zhang Z, Hou X, Jian M, Wang Y, Liu H, Wang A, Han R, Liang F. Oxygenation targets for endovascular therapy in acute ischemic stroke patients (Oxy-TARGET): protocol for a single-centre, open-label randomised controlled trial. BMJ Open. 2025 Jan 4;15(1):e086234. doi: 10.1136/bmjopen-2024-086234. PMID 39755573

Идентификаторы

NCT: NCT06224426 · zkd20231121

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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