Effects of High Flow Oxygen Therapy on Oxygen Desaturation Index in Patients With Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Oxygen desaturation index
研究概览
简要总结
Hypoxemia is common in acute ischemic stroke and associated with neurological deterioration and mortality. However, the benefit of oxygen therapy is controversial. Severity of stroke may affect the benefit of oxygen supplementation. Abnormal breathing patterns are commonly found among stroke patients and may increase the risk of hypoxemia. High flow nasal cannula (HFNC) has several advantages from controllable fraction of inspired oxygen (FiO2), reduction of nasopharyngeal resistance and positive end expiratory pressure effect. In this study, we aimed to assess the therapeutic effect of HFNC on oxygen desaturation index (ODI) and neurological outcomes in stroke patients with moderate and severe severities, compared with no and low flow oxygen supplementation.
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
- None
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 of 18 or more
- •Clinical and radiographic findings including computerized tomography of brain compatible with acute ischemic stroke
- •Presentation within 72 hours after the stroke onset
- •National of Health Stroke Scale (NIHSS) of 5 or more,
- •Limb weakness defined as motor power grade of 4 or less,
- •Able to give informed consent, or the next of kin was willing to give assent
排除标准
- •Recognized indications for oxygen treatment, such as oxygen saturation on room air of less than 92%, acute left ventricular failure, severe pneumonia, pulmonary emboli, and chronic respiratory failure treated with home oxygen supplementation
- •Recognized contraindications for oxygen treatment including chronic hypercapnia and type II respiratory failure
- •Subjects with previous diagnosis of obstructive sleep apnea (OSA) or highly suspicious of OSA, screened by STOPBANG score of 5 or more
研究组 & 干预措施
No oxygen
No oxygen supplementation given
Low flow oxygen
Oxygen cannula with a flow rate of 2 liter/minute
干预措施: Low flow oxygen (Device)
High flow oxygen
Heated humidified high flow oxygen cannula (Optiflow; temperature of 34°C and fractional inspired oxygen of 0.24) with a flow rate of 20 liter/minute
干预措施: High flow oxygen (Device)
结局指标
主要结局
Oxygen desaturation index
时间窗: In the first 24 hours of study period
The number of times per hour that the oxygen saturation measured by pulse oximetry drop from baseline more than 4% for at least 10 seconds
次要结局
- The number of subjects with oxygen desaturation(In the first 24 hours of study period)
- Mean oxygen saturation(In the first 24 hours of study period)
- Percentages of cumulative time of oxygen desaturation(In the first 24 hours of study period)
- The number of subjects with NIHSS improvement by 4 or more(at the 7th day of admission or at discharge date)
- Lowest oxygen saturation(In the first 24 hours of study period)
- NIHSS changes(at the 7th day of admission or at discharge date)