Effect of Body Position on Hemodynamics in Patients With Acute Ischemic Stroke Undergoing Ultra-early Reperfusion Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Differences in heart rate variability (HRV) between different positions
研究概览
简要总结
The aim of this study was to determine the differences in hemodynamics between different positions in patients undergoing ultra-early reperfusion therapy.
详细描述
Hemodynamic stability can prevent hypoperfusion or hyperperfusion after reperfusion therapy. It has been reported in a large number of literatures that body position has an effect on hemodynamics, but the effect of different body positions on the hemodynamics of patients undergoing ultra-early reperfusion therapy is not clear. In this study, we hypothesized that the hemodynamics of patients undergoing ultra-early reperfusion therapy would differ between different positions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years, < 80 years, regardless of sex；
- •Patients with clinically confirmed acute ischemic stroke who received intravenous thrombolysis or emergency endovascular treatment;
- •Baseline National Institute of Health stroke scale（NIHSS）score ≤25;
- •Baseline Glasgow Coma Scale (GCS) ≥8;
- •Signed and dated informed consent is obtained
排除标准
- •The patient has clear indications or contraindications, such as active vomiting, spinal cord injury；
- •Clinicians considered that the assigned body position could not be maintained; Patients unable to cooperate with all noninvasive beat-by-beat continuous BP monitoring;
- •Poor temporal window penetration;
- •Patients with diseases that seriously affect hemodynamics, such as atrial fibrillation, anemia, and hyperthyroidism;
- •Previous history of atrial fibrillation or ECG showing atrial fibrillation or arrhythmia;
- •Pregnant or lactating women;
- •Poor treatment compliance;
- •Complicated with severe systemic diseases, such as heart failure, respiratory failure, renal failure, gastrointestinal bleeding, coagulopathy, malignant tumors.
研究组 & 干预措施
Zero position
All monitoring was done from 9 to 11 a.m., and the whole monitoring process was carried out in a specific and quiet environment at 20-24℃ to avoid other auditory and visual stimuli. After 10min of the relaxed supine position, the blood pressure, heart rate, and blood flow velocity of the middle cerebral artery were measured in the 0° position for 5min.
干预措施: Transcranial Doppler. (Device)
30 degrees position
Within 30 seconds after the 0° position measurement completion, the subjects were transferred to the 30° position and rested for 15 minutes under the 30° position. In other words, a washout period of 15 minutes was established between two measurements to ensure the stability of vital signs and avoid confounding effects. The blood pressure, heart rate, and blood flow velocity of the middle cerebral artery were measured again for 5 minutes after the vital signs were stable.
干预措施: Transcranial Doppler. (Device)
结局指标
主要结局
Differences in heart rate variability (HRV) between different positions
时间窗: 0-7 days
HRV is defined as heart rate oscillations in relation to the mean values.
Differences in blood pressure variability（BPV）between different positions
时间窗: 0-7 days
BPV is defined as blood pressure oscillations in relation to the mean values.
次要结局
- The difference of middle cerebral artery blood flow velocity between different positions.(0-7 days)
研究者
Yi Yang
Associated Dean of The First Hospital of Jilin University
The First Hospital of Jilin University