The Safety and Feasibility of Normobaric Oxygen Administration for SUSPEcted Acute Stroke uNder Pre-hoSpItal cONdition--A Pilot Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time intervals of the prehospital transportation process
研究概览
简要总结
The primary purpose of this study is to explore the feasibility and safety of normobaric oxygen therapy (NBO) under pre-hospital condition in patients with suspected stroke.
详细描述
Despite the application of thrombolytic drugs and endovascular treatment, there is still a gap between the successful recanalization and ideal clinical outcomes for stroke patients. Neuroprotective treatment is considered as a promising adjuvant to ameliorate this situation. Previous researches demonstrated the neuroprotective effects of Normobaric Hyperoxia (NBO) in animal models from multiple perspectives. Moreover, NBO is distinctive for its ubiquity, conveniency, high compatibility, and wide adaptability, making it superior to other neuroprotective interventions in a pre-hospital setting. Therefore, the investigators conducted this pilot study to further explore the feasibility and safety of NBO under a pre-hospital condition in patients with suspected stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or more.
- •Suspected stroke screened by the "Gaze- Face Arm Speech Time" scale (G-FAST score ≥ 1).
- •Within 24 hours of symptom onset
- •SpO2 > 94%.
排除标准
- •Coma: Glasgow coma score (GCS) <
- •Hypoglycemia: Blood glucose < 2.8mmol /L.
- •Known history of seizure.
- •Recent stroke or brain trauma within past 30 days.
- •Previous Modified Rankin Scale (mRS) ≥
- •Rapid improvement of neurological dysfunction (deficit present less than 15 min).
- •Unstable vital signs.
- •Known respiratory distress, respiratory dysfunction, or any contraindications to high-flow oxygen inhalation therapy.
- •Patient unable to cooperate with the trial procedure.
- •Any condition which might increase the risk to the patient in the judgment of the investigator.
- •Patient or available legally authorized representative unable to provide written or witnessed oral consent.
研究组 & 干预措施
Normobaric Oxygen Inhalation Group
Participants in the intervention group will receive oxygen inhalation through a mask at a rate of 10 L/min at 1 absolute atmosphere pressure (1 ATA = 101.325 kPa) after randomization until adimisson to the hospital. Participants will subsequently receive standard diagnosis and treatment service according to the guidelines during hospitalization.
干预措施: NBO (Drug)
结局指标
主要结局
Time intervals of the prehospital transportation process
时间窗: Day 1
Time intervals between stroke onset, paramedic arrival on the scene, the departure from the scene, and admission to the hospital emergency department.
次要结局
- Safety Outcome(Day 1)
- Recruitment rate(From the date of recruitment initiation until the date of recruitment completion, assessed up to 24 months.)
- Systemic immune-inflammation index (SII)(Day 1)
- Final diagnosis(From the date of recruitment initiation until the date of recruitment completion, assessed up to 24 months.)
- Neutrophil-to-lymphocyte ratio (NLR)(Day 1)
- Plateletto-lymphocyte ratio(PLR)(Day1)
研究者
Ji Xunming,MD,PhD
Principal Investigator
Capital Medical University